tag: iso 13485

ISO 13485:2016 Benefits

May 2, 2023 | electronic assembly, iso 13485, iso 13485:2016, pcb assembly, pcba, quality certifications, regulatory requirements, risk management process What are the Biggest ISO 13485:2016 Benefits? ISO 13485:2016 is an international standard for quality management systems specific to the medical device industry. It...Read More

ISO:13485 Benefits

June 23, 2022 | increased efficiency, iso 13485, medical, pcba, printed circuit boards, process improvement, regulation requirements, safety, worldwide access What is ISO 13485? ISO 13485 is a medical device manufacturing certification that ensures customers of the regulations and procedures necessary for product development....Read More

Design for a Medical PCB Assembly

December 10, 2021 | ipc class 3, iso 13485, medical devices, medical pcba, pcb assembly, pcba, safety first, SMT, thru-hole mount Playing the Game When it comes to medical devices, no average or sub-par printed circuit board assembly (PCBA) is going to cut it! In...Read More