Medical device manufacturing and marketing in the U.S.A. is regulated by the FDA. Medical device manufacturers must register with the FDA and produce their products with a Quality System that meets the FDA Quality System Regulation and more precisely with the 21 CFR 820. Compliance with regulations is crucial and requires an investment of both time and money. Contract manufacturers play an increasingly crucial role in achieving compliance. Choosing the right partner is vital for complying and obtaining FDA approval for your device, even more so since 21 CFR 820 might one day be supplanted by ISO 13485:2016. As an FDA registered and ISO 13485:2016 certified company, Valtronic knows what is required and how to be best prepared for inspections. We support our customers with highest Quality performance.

What is 21CFR 820?

Medical device manufacturers are required to produce their product under an established Quality System that meets the FDA Quality System Regulation and more precisely the (QSR) Title 21 CFR Part 820. The Quality System for FDA-regulated products (food, drugs, biologics, and devices) is known as current Good Manufacturing Practices (cGMP’s). Since FDA regulations apply to a broad array of devices, they do not define in detail how a manufacturer must produce a specific device. The regulation rather provides a general framework for manufacturers to develop Quality System policies and procedures that ensure their device is produced following cGMP’s.  To demonstrate that a Quality System has been established, implemented and maintained, objective evidence is required in the form of a Quality System Record (QSR) which includes documents and records that can be reviewed by the FDA during an inspection.

Establishing a regulatory quality system can be very demanding in terms of time and investment

The investment of time and money into a substantive regulatory and quality system for the manufacture of medical devices pays off in many ways. It mitigates risk, reduces long term costs by avoiding or diminishing rework, increases customer confidence and most importantly, it allows for a safe product for the patients. The way to the finish can be long depending on the complexity of your device, and the level of supporting documentation that is required.

What about your suppliers and contract manufacturers?

Your suppliers and CMs play a crucial role on your way to compliance with the 21CFR 820.  Section 820.50 of the Regulation specifically addresses purchasing controls. Procedures are required to ensure that all purchased products and services conform. This includes your contract manufacturers which you have to evaluate and select on the basis of their ability to meet specified requirements, including quality requirements. The evaluation must also be rigorously documented where the level of supporting documentation needed depends on complexity of the device and on the work your CM performs on your device. So make sure to choose a contract manufacturing partner like Valtronic who makes quality a priority.

What if FDA decides to fully adopt ISO 13485:2016?

The FDA intends to harmonize and modernize the Quality System regulation for medical devices. Last year, it announced a new proposed rule aiming at “Harmonizing and Modernizing Regulation of Medical Device Quality Systems”.  The revisions will replace existing requirements with the specifications of ISO 13485:2016. They are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. For manufacturers who now only comply with 21 CFR, this change will represent a new challenge in terms of work and investment to meet the requirements.  And for those who already comply with ISO 13485:2016, choosing a contract manufacturer who also complies with both certifications can be of considerable support. Valtronic‘s highly qualified quality team is a huge asset for current regulatory requirements and any upcoming regulation changes which also includes the new MDR – Medical Device Regulation. We are ready, what about you?