With the exception of a few Class I devices, medical devices sold in the United States need to be designed and manufactured in compliance with the FDA’s Quality System Regulations (QSR – 21 CFR Part 820). FDA has stated that IVD MIA products will also need to be compliant with QSR. In order to sell devices in Canada, the European Union (EU) and many other countries, compliance with International Standards Organization (ISO) 13485 is also required.
QSR and ISO 13485 are in effect a series of procedures and documents that ensure design of products is documented and testing that validates the design is performed, the manufacturing of products is performed consistently and that raw materials with known quality are utilized and that products are supported once they are marketed via a robust complaint process. Medical device manufacturers are regularly inspected to ensure compliance with the QSR. If compliance with ISO 13485 is desired, an initial inspection by a Notified Body (BSI, UL, etc) is required to obtain certifications and annual inspections are needed to keep certification current.
QSR and ISO 13485 are not harmonized. For example, ISO 13485 requires a vigilance system that is more proactive than the FDA’s required complaint system. However, there are enough similarities that very few ISO specific procedures will be required and if planning for both requirements is performed prior to creating the system, compliance with both can be attained.
Adhering to the QSR or ISO 13485 requires significant resources within a company. Both initial set-up of the system and ongoing support will be required.
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