ISO 13485:2016 is an international standard for quality management systems specific to the medical device industry. It is based on the generic ISO 9001:2015 standard, but with additional requirements that are specific to the medical device industry.
The standard is particularly relevant for companies that manufacture electronic assemblies for use in medical devices, as these assemblies must meet strict regulatory requirements and high-quality standards to ensure the safety and efficacy of the final product.
Meet Requirements
One of the main benefits of ISO 13485:2016 for electronic assembly manufacturers is that it helps them to meet regulatory requirements. Medical devices are subject to strict regulations, both in terms of product design and manufacturing. ISO 13485:2016 provides a framework for organizations to demonstrate that they are meeting these requirements, which can make it easier to obtain regulatory approvals and market their products.
Improve Quality
Another benefit of ISO 13485:2016 for electronic assembly manufacturers is that it helps them to improve their overall product quality. The standard requires organizations to establish and maintain processes for controlling the design, development, production, and delivery of their products. This ensures that products are high quality and meet the requirements of customers and other stakeholders.
Improve the Risk Management Process
ISO 13485:2016 also helps electronic assembly manufacturers to improve their risk management processes. The standard requires organizations to identify and evaluate risks associated with their products, and to implement measures to control these risks. This can help to reduce the likelihood of product defects and recalls, which can be costly and damaging to a company’s reputation.
Additionally, for electronic assembly manufacturers, the standard requires ensuring that the electronic assemblies are in accordance with safety standards such as IEC 60601-1 and EMC standards. This guarantees that the assemblies conform to the requirements of the medical device, thus ensuring the safety and efficacy of the final product.
Certified Safe Medical Devices
For medical device customers, one of the main benefits of working with electronic assembly manufacturers that are certified to ISO 13485:2016 is that they can be confident that the products they receive are of high quality and meet regulatory requirements. This can help to reduce the risk of product defects and recalls, and ensure that the electronic assemblies are safe and effective for use in medical devices.
Conclusion
In conclusion, ISO 13485:2016 provides a framework for electronic assembly manufacturers to demonstrate that they meet regulatory requirements, improve product quality, manage risks effectively, ensure compliance with safety and EMC standards, improve internal processes, and ultimately improve their overall performance. Medical device customers who work with manufacturers that are certified to ISO 13485:2016 can be confident that the electronic assemblies they receive are safe, effective, and meet industry standards.
It is important to use an experienced printed circuit board assembly (PCBA) manufacturer like PGF Technology Group to ensure that your PCBs are made to the highest quality standards and meet your specific requirements. With years of experience and state-of-the-art machinery, PGF Technology Group is well-equipped to handle all your PCBA needs. They have a team of experts who are knowledgeable in all aspects of the PCB assembly process.
Electronic Manufacturing Services (EMS) providers are companies that specialize in the design and manufacture of electronic products, from simple PCB assemblies to complex devices such as smartphones and medical equipment. When it comes to pairing with the perfect EMS provider, several best practices can help ensure that your project finishes on time, within budget, and to your specifications.
1. Clearly Define Requirements
First and foremost, it’s important to clearly define your project requirements. Before engaging with an EMS provider, take the time to clearly define what you need in terms of the product’s specifications, including any performance requirements, regulatory compliance, and the final product’s desired form factor. This will allow the EMS provider to properly assess the feasibility of the project and provide an accurate quote. Furthermore, it will help in avoiding any miscommunication, or misunderstanding during the production process.
2. Look for Expertise in Your Industry
Additionally, it’s important to work with an EMS provider that has experience and expertise in your specific industry. Many EMS providers have specialized in certain industries, like medical, automotive, or IoT, and will have a deep understanding of the unique requirements and challenges that come with those industries. They will also be able to advise on new innovations and materials to ensure the product meets the necessary compliance regulations. Tip: research certifications, such as ISO 13485 or 9001, to see the capabilities of different companies.
3. Chat with Them Openly
It’s also important to establish strong and open communication with your EMS provider throughout the production process. This means being available to answer questions and provide feedback promptly, and keeping the EMS provider informed of any changes to the project or production schedule. In action, this form of interaction helps to minimize delays and ensure that the production is according to your specifications.
4. Scout for Modern Equipment
When it comes to the production process, it’s advised to work with an EMS provider that utilizes modern and high-tech manufacturing equipment. This includes things like automated pick-and-place machines, reflow ovens, and advanced testing equipment (AOI Inspection, X-ray Evaluation, etc). Using modern equipment helps ensure that your production is efficient and highly accurate, which helps to reduce the chance of defects and improve the overall quality of the final product.
5. Spot the Control on Quality
Quality control is another crucial component to consider when working with an EMS provider. This means that the provider should have a robust quality management system in place, including inspection and testing procedures, to ensure that your product meets your specifications and complies with any necessary regulations. It’s also important to review the provider’s quality records, to get an idea of their past performance and identify any potential areas of concern.
6. Review Supply Chain Management Skills
In terms of materials, review the provider’s supply chain and logistics capabilities. This means assessing the provider’s ability to source materials, components, and subassemblies promptly, and managing the logistics of getting the materials to the production facility. Having a reliable and efficient supply chain is critical to ensuring that your product is produced on time and within budget.
7. Seek After-Sales Support
Finally, it’s best practice to choose an EMS provider that offers comprehensive after-sales support. This includes things like repair and maintenance services, product updates, and end-of-life support. This will ensure that your product stays in good working condition and is supported throughout its entire lifecycle.
Now, It’s Up to You!
In conclusion, when working with an Electronic Manufacturing Services (EMS) provider, it is important to define your project requirements, work with a provider that has experience and expertise in your specific industry, establish strong and open communication, utilize modern and high-tech manufacturing equipment, have a robust quality management system, review the provider’s supply chain and logistics capabilities, and choose an EMS provider that offers comprehensive after-sales support. By following these best practices, you can help ensure that your project is completed on time, within budget, and to your specifications. Whether Printed Circuit Board, Cable, Wire Harness, or Box Build Assembly, the provider you work with is a reliable and trustworthy partner for your future projects as well.
Even the most competent organizations tend to face market competition. What are the strategies employed by you to thwart this competition? What, according to you, are the company’s key differentiating factors?
As in any large industry, PGF faces market competition in all aspects of its manufacturing services, from cable to PCB assembly. Naji Gebara employs his strong leadership skills and community-based strategy against all competition. The main differentiating factors include team unity, company transparency, and service capability. Employees utilize immense teamwork and advanced technologies with each project to meet customer specifications with high-quality products. Additionally, as a solutions provider, PGF maintains complete transparency with customers to ensure absolute satisfaction and a strong manufacturing relationship.
Unity
The most significant advantage held by PGF is the unity of our teams. From Naji’s ambition to move forward, he brings an entire team with him past the finish line. With the second core value noting that employees are treated as family, the encouragement of others can be found in every step of the process. With a spotlight on new market trends, our internal focus on our members’ preparedness shines through conversations with potential customers and suppliers. As one team, PGF can meet deadlines, produce quality work, and continue to grow.
Transparency
For PGF, our vital differentiating factors include transparency and the need to provide solutions. In short, PGF is a solutions provider. We will give honest feedback to prospective and customer contacts. In order to move forward through any PGF project, customers are guaranteed all questions are answered swiftly and efficiently. Tracy McGraw, the Manufacturing Manager from Essen Bioscience, noted,
“We sincerely appreciate your responsiveness and the way you conduct business…When placing an order with PGF, we received exceptional customer service with extensive product knowledge” (Tracy McGraw, Essen Bioscience).
This testimonial notes one instance of our dedication to customers in any project. Whether it be providing unique prototype services or additional steps for cable assembly, PGF is willing to adapt to the project at hand
Capability
Furthermore, a focus on well-rounded capabilities means that our facility handles printed circuit board, box build, and cable/wire harness assembly services. These new areas of expertise allow us to contribute that much more to our customers. Each service provided broadens the scope of the PGF future. Although market competition may be present, PGF allows customers to engage in multiple orders, services, and projects from a single and trustworthy company. The ability to produce high-volume orders showcases the strength of PGF and differentiates itself from other manufacturers within the industry.
PGF Market Competition Strategy
The key to facing market competition is to compete with yourself first. As a practice that PGF stands for, fear not your competitor but your ability to perform. The PGF focus remains on increasing productivity, customer satisfaction, and raising internal expectations. Learn more about the selection of PGF capabilities and request a quote today!
What are the latest technologies enhancing the business that you have been proactively implementing? What will the PGF Technology Group’s future be?
With each release of the latest trusted technologies, PGF integrates machinery to advance high-quality assembly practices. At PGF, enhancing business translates to added technology throughout all assembly steps. For example, cable machines assist in wiring methods while PCB machines introduce more efficient PCB techniques. The future of PGF includes immense opportunities for growth with success both in monetary gain and individual development.
Edge of Technology
The drive to constantly be on the edge of the next technological advancement is a PGF core value. PGF Technology Group is always utilizing the latest tools and practices. Additionally, this drive comes from researching possible new industries of interest and prepping our facility to handle the most advanced projects. Across all PGF services, from cable assembly to prototyping, the company continues to integrate trusted technologies. After all, if a company is not continuously growing, it falls behind.
Investment
Yearly states of analysis give us the power to determine areas where improvement can bring the most progress. Everything starts with a plan and builds until it’s ready to be built again. This year, PGF is developing online training courses for new and tenured team members to deepen their skill sets and advance their careers – and PGF as a whole. The company has also digitized work instructions to create a more efficient assembly process, especially for new PGF members to accelerate their understanding of the procedures.
Additionally, we have updated our facility’s layout to increase resourcefulness and enhance workflow from concept to quality check to delivery. After all, a greatly flowing river becomes harder and harder to stop, just as PGF’s progress is becoming harder to slow down. A yearly investment of 2-5% of the annual budget goes toward machine updates. All in all, this facility update includes the universal usage of more automated tools over their manual counterparts, effectively improving assembly time and accuracy.
The PGF Future
PGF can summarize its future in one word: Growth. Each team member‘s improvement works to bring new perspectives and opportunities to our partners. As CEO, Naji Gebara leads the company by lifting others while openly accepting constructive criticism as a means of progress. Adding internal employee skillset builder modules demonstrates PGF’s devotion to improvement. Overall, we expect to expand our services to include more design capabilities and extend our properties to continue expediting the assembly process. Learn more about PGF capabilities and request a quote today!
What is one of the biggest achievements of your organization owing to its revolutionary approach and your creativity? How does Naji Gebara deal with criticism as a leader?
The success of a CEO constitutes the biggest achievement of the organization as a whole. For Naji Gebara, success translated into the ability to take hold of as many opportunities as possible. Directly related to the PGF revolutionary approach and creativity, the best achievements lie in monetary gains and improved leadership. However, as with any position of authority, constant review and suggestions follow each decision. Yet, Naji Gebara takes constructive criticism openly, regarding each comment as an opportunity for growth.
Company Growth
Since Naji Gebara’s complete acquisition of PGF, one of his most outstanding achievements has been doubling the business of this already well-established company. Year over year, double-digit growth rates show the outcome of hard work. However, this increase in PGF’s growth rate is not due to hard work alone. Every significant step of progress began as a vision that came to fruition. From daily overviews to weekly metrics, a data-driven company reveals the secrets to achievement. In other words, the numbers don’t lie, so use them to find the truth.
Leadership
This profit-driven advancement stems from a leader motivated by the thrill of the chase. Of course, money determines success outwardly, but internally, the anticipation for new opportunities determines longevity. With each achievement, Naji continues to assess the ways to improve as a leader to better work with others. Whether through open communication, in-depth meetings, or employee lunches, Naji takes the leadership responsibility seriously. As the company continues to grow, Naji’s leadership tactics grow alongside it.
Improvement
Naji Gebara welcomes constructive criticism because it means the chance for improvement. As the common phrase in meetings, “If you disagree with me, please let me know,” suggests, he constantly seeks new perspectives from those around him. With each review, comment, and suggestion, Naji improves his approach to leadership. Beyond monetary measurements, comfort and individual achievements of PGF employees contribute to overall CEO success. Everyone has specific positions within PGF, but we are a team that benefits from each other’s suggestions and achievements.
The PGF Difference
Naji Gebara actively leads PGF as a company with a purpose beyond monetary success and one of innovation and ambition. Customers are guaranteed high-quality products while supporting a company integrating advanced technologies for further improvement. From lifting other businesses to providing internal promotion and success exemplifies the PGF difference. Work with a company that values the success of others and request a quote today!
What are some of the leadership lessons Naji Gebara has learned in his career experience? How does he incorporate those into the company’s culture?
Naji’s beginning on the shop floor broadened his inner knowledge while growing his perspective of the PGF team. Just as the assemblies became more and more complex, the insight gained by Naji continuously expanded. This hands-on experience guides him to provide leadership without empty promises but rather knowledge-based fundamentals. From this standpoint, the training process became evident in a two-step summary: (1) Give them the tools and (2) Let them dream about new ways to excel. By allowing for creativity and utilizing his leadership lessons, Naji Gebara is giving the PGF team the room to grow exponentially.
The Tools
In following the first step of the PGF training process, employees can employ personal creativity and ideas. Training modules, strong leaders, and an open environment are critical to providing individuals the opportunities to grow and succeed. From project leaders to PCB floor managers, employees interact and learn with all members of PGF. After all, Naji encourages employees to reach their highest potential through a supportive work environment with personal and career-focused opportunities.
The Dream
To promote a supportive environment amongst co-workers and leaders, Naji motivates employees to dream about new ways to excel. With plans to improve workstations, enhance employee skill sets, and integrate cutting-edge technology, the PGF company culture continues to head toward progress and success. Likewise, Naji’s journey from cable assembler to CEO demonstrates the endless growth opportunities at PGF.
The Values
PGF’s second core value notes that employees are like family. As a small business, this understanding marks PGF as a company that has kept the family feel within a corporate structure. This family grows through job-specific teams and well-versed leaders while providing high-quality work. Additionally, Naji’s leadership lessons and family mindset lead to the other two company values. These values state that customers are the priority, and innovation is a continuous process.
The PGF Team is a PGF Family
Above all, the leadership lessons fostered from Gebara’s personal experience shape the PGF team as a PGF family. With many PGF leaders starting with Naji over a decade ago, the PGF family is a strong and inviting group. All in all, PGF motivates employees to utilize the tools provided and express personal creativity for personal and corporate success.
For every project, the Electronics Manufacturing Service Provider (EMS Provider) strives to enable partners on-time delivery (OTD) services. The initial conversations between provider and partner are necessary to establish the proper steps to success. Overall, these conversations develop the needs of the project at hand and indicate priorities for the build. Delivering on-time services is critical for customer service and proper project completion.
Setting the alarm before bed takes careful consideration. How many times will you press snooze? When will you eat breakfast? How long does it take for you to do your signature hair-do?Similarly,setting the timer for a project takes thoughtful deliberation. Key factors include expertise, staffing, technology standards, and transparency on the supplier side.
Expertise
Firstly, an experienced supplier should effectively build their services to support their customers’ needs. In practice, these solutions extend past assembly to industry knowledge. To strive for on-time delivery, a supplier should:
Evaluate Obsolete Parts
Check End-of-Life Parts
Assess Lead Times
Review Applications for Components
Provide Substitutions/Alternatives
Overall, experience in the industry allows certain suppliers the inner know-how to navigate component acquisition and potential production time.
Staffing
Knowledge alone cannot prevent sleeping through the alarm. Proper employee training in the correct positions is crucial to waking up refreshed and ready to go!
If a company is understaffed and overworked, the delivery goal will be much harder to reach. Regular assessments of business practices, managerial roles, and training practices must occur to counter this problem. Establishing effective training procedures and recognition allows the right employee to fill a vital position.
After all, companies operating with the best person for each task are guaranteed to create an efficient production process with fewer snooze button hits.
Technology Standards
Coupled with the right team, establishing top-notch technology and machinery streamlines production processes wherever possible. For instance, Surface-Mount Technology (SMT) machines perform PCB Assembly tasks such as component placement more quickly than complete manual assembly.
For companies searching for a supplier, it is essential to visit the facility or receive a list of the machinery they can equip for your project. Furthermore, if your project is for a growing industry, such as Electric Vehicles, evaluating the machinery for its longevity eliminates future supplier changes and production delays.
Transparency
On the whole, constant updates reassure the customer that the supplier has their best interest in mind. This honest feedback incorporates positive and negative situations involved with a project’s progress. For example, suppose a supplier becomes aware of a pending issue that will delay the procurement of specific components if a different course is not taken. In that case, they should immediately notify the customer to plan an alternate solution and maintain trust.
These constant discussions could generate new ideas to continue the path to on-time delivery, even when blocks seemingly get in the way.
Avoid Hitting the Snooze
In summary, with a customer’s keen attention to supplier services and the supplier’s constant assessment of their capabilities, partners can achieve on-time delivery even in times of supply chain turmoil. The final piece of advice is for both parties to have realistic goals. Especially during component shortages, everyone should review the path to production with the goal of re-defining order periods and lead times. With all of these tips in mind, springing out of bed at the first alarm should come easily!
How are you assisting aspiring entrepreneurs working hard to get their business off the ground?
The role of a CEO requires both internal motivation and external support for all business-minded individuals. Naji Gebara builds relationships with customers to assist aspiring entrepreneurs as they continue to work hard and improve their businesses. Additionally, Gebara takes direct action in encouraging a business plan and promoting ambitious innovation.
Business Plan
By beginning with a business plan, focusing on core values, and working hard in all aspects of the company, Naji Gebara knows the road to success means determining the perfect map. Entrepreneurs write their maps as they cartograph new paths into exciting business spaces; they must always have a vision and aspirations for this journey. However, aspiring entrepreneurs cannot live in the future; they must work toward it. PGF can advise this work due to our experience in the industry. In addition, Gebara’s industry knowledge provides entrepreneurs with the necessary assistance to create the right business plan for each project.
Prototype Services
Naji Gebara and PGF are constantly accommodating new businesses with their latest projects. By offering prototype services and low-volume verification, PGF gives new partnerships the time to grow and succeed through thoughtful product integration and in-depth discussions about future activities. After all, using PGF prototype services showcase Naji Gebara’s devotion to quality products, services, and customer relationships.
Ambitious Innovation
Additionally, PGF’s ability to predict future trends and prepare for ambitious innovation allows up-and-coming businesses to trust us with cutting-edge ideas. After all, one of our core values notes that innovation is a continuous process. This innovation includes implementing digitized work instructions, automated quality check machines, and expanded facility space to anticipate future work. Furthermore, Naji’s implementation of technological advances into the manufacturing process improves PGF products and services, leaving opportunities for growth and assistance of other entrepreneurs. PGF is prepared to encourage and work with aspiring entrepreneurs with such company upgrades.
PGF Leadership: Lifting Entrepreneurs
Naji Gebara’s experience starting as a cable assembler and working up the ladder to current CEO showcases his journey as an aspiring entrepreneur. In taking leadership, Naji has improved PGF tremendously and encourages others through the variety of services offered within the company. From drafting a business plan with customers to internally maximizing efficiency, PGF promotes effective business strategies across the company. All in all, Naji demonstrates PGF leadership as high-quality performance that leaves customers satisfied and lifts aspiring entrepreneurs.
Please describe some of Naji Gebara’s traits that have helped the organization succeed.
Naji Gebara’s industry knowledge, constant-learning ambition, and forward-thinking mentality have helped PGF excel in the electronic manufacturing industry. Every year, following his lead, brings further growth and aspirations for the long PGF road ahead. With each project and this “CEO success,” PGF provides all customers with timely, affordable, and high-quality products and services.
Industry Knowledge
By starting at PGF as an assembly worker and moving up the ladder to CEO, Naji has already grown with PGF and is constantly pushing to surpass the next limit. This experience has given him the knowledge of prominent companies, business tactics, and best assembly practices. It is also noteworthy that many of the team members that started with Naji initially are still working at PGF decades later, accomplishing high-quality assembly projects. Gebara’s widespread industry knowledge effectively translates to exceeding customer expectations, while constantly growing PGF success.
Constant-Learning Ambition
Naji introduced himself to many cultures at a young age, where he learned quickly to excel in new spaces. After years of advanced schooling to receive a Doctorate of Engineering in Manufacturing Systems, Naji returned to PGF to lead the company into the next few decades. From this point on, Naji went from learning the languages of new countries to teaching the language of business. With his leadership role at PGF, Naji also spent some time teaching classes at Lawrence Technological University to advance future business-minded students in their endeavors. This learning mindset keeps PGF constantly moving forward, emphasizing the edge of technological advances.
Forward-Thinking Mentality
When PGF began, it was a cable assembly company featuring simple assemblies for select industries. After years at the helm, Naji brought PGF into new opportunities by acquiring fellow Electronic Manufacturing Service (EMS) companies, new property, experts, and machinery. PGF Technology Group became a full-service electronics manufacturer, offering printed circuit board and cable assembly services. Over time, assemblies became more complex, and customers became more high profile. Today, we assemble turnkey solutions for the top companies in industries such as Aerospace, Electric Vehicles, Medical Devices, and Robotics. Looking forward, Naji intends to pursue larger manufacturing projects as well as advance internal employee skillsets. To further promise timely assembly work, Gebara continues to integrate technological advances for optimal manufacturing processes and PGF products overall.
Customer Satisfaction is PGF Success
PGF Technology offers a variety of services from printed circuit board assembly to wiring harness assembly to companies around the world. CEO Naji Gebara continues to play a crucial role in the progression and success of PGF. Most notably, Gebara’s strengths cultivate a PGF reputation for timely, affordable, and high-quality services. Naji’s strong leadership confidently improves internal assembly and company structure, while fostering customer relationships to conduct universally favorable business.
You are searching for a manufacturer on the edge of technology to partner with for your new PCB assembly project.
Company A and B both offer low volume, high mix capability for PCB assemblies. Company A has the most effective technology to perform highly replicable automated processes alongside manual assembly. At the same time, Company B relies on mainly manual labor and has not replaced its machinery in 10 years. Both assembly methods can be effective, but one shortens the timeline and increases product accuracy.
Which company do you choose?
What Does “Edge of Technology” Mean?
The phrase “Edge of Technology” refers to a company constantly remaining ahead of the curve in the latest machinery and equipment. Specifically, this phrase has a connotation that includes a look into the future. In essence, I mean that the word “edge” alludes to something about to move forward; it predicts movement that propels and builds kinetic energy. To clarify, an edge represents the end of a corner and the beginning of another, forcing a step onward.
As can be seen in manufacturing, staying informed about upcoming trends and techniques allows a company to predict its next moves in new machine purchase, installation, and usage.
Why is it Important to Be Constantly Innovating?
Ultimately, the push to constantly innovate is about staying one step ahead of the customer and competition. In terms of a partnership, both sides must match up to expectations. For example, if a customer requires the newest model of a specific machine that you do not have, then they will find a different partner.
Electronic Manufacturing Suppliers (EMS) must think about a customer’s future projects. To be a proper solutions provider, you have to answer the question before it’s asked. This practice begins with prediction, preparation, and execution. In this case, a manufacturer must reflect on:
For which industries do I want to do assembly?
Specific industries may have certain technologies that manufacturers must use to complete a project. This distinction is especially true in advanced Medical Devices and the highly inventive EV Power Industry.
Where are these industries headed?
Any manufacturing company must remain privy to the advances driving ambitious projects. From trade shows to industry updates, companies have to envision the next direction for their current and potential customers.
What machinery do the potential projects require?
In order to prepare for the future, companies must have close relationships with their customers to learn about the needed machinery. Collaborations between growing businesses allow for a wide range of innovation with an emphasis on state-of-the-art equipment.
PGF Machinery and Equipment
At this point, for PCB Assembly, Cable Harness Assembly, and Wire Processing, PGF utilizes advanced operational technology.
With an array of Schleuniger machines for crimping, stripping, and terminating, wires can be processed and sorted quickly with a team of skilled workers operating the machine and perfecting the project.
On the other (electronic) side, Selective Soldering machines, Solder Paste Inspection (SPI), and Surface-Mount Technology (SMT)linesplace components accurately on their respective PCBs and use reflow soldering to keep them in place. Our team utilizes a Fuji Line and MyData Line to assemble various volumes of PCBAs.
An X-Ray machine, In-Circuit Testing devices, and Automated Optical Inspection (API)machines allow close quality inspection. These machines act as second eyes to check PCBA performance.
With many additional automated and hand equipment, we raise the bar to move forward continuously.
Transparency
Investment 
Technology Standards
