Medical Device QMS: What It Is, Where It’s Required, and Key Regulations to Know.
If you are in the medical device field, you must be aware of the word QMS ( Quality Management system ) for Medical Device. However, detailed knowledge with right interpretation of compliance requirement is must. Each clause needs to be understood with usual approach of what, where why and how. Each must be answered without any ifs and buts. ISO 13485 is universal international standard which describes all elements of QMS for medical device. This is followed in Europe, Canada and Australia and other countries except USA. USA follows its own standard 21CFR part 820. Though Brazil and Japan have their own standard but those are based on ISO 13485 and FDA QSR. ISO 13485 is standard for QMS documentation for medical devices Apart from this Europe also had MEDDev regulation which is now got replaced with MDR which also describes certain special requirements. This regulation is also must for compliance if you want to enter European market. For USA 21 CFR part 620 compliance i...