Smith Associates can assist small and large companies in writing and implementing their Quality System, or enhancing their ISO Quality System to conformance to Part 820. Our Standard Operating Procedures, Forms and Work Instructions have been implemented, audited and inspected by the FDA and has successfully fulfilled the FDA’s requirements.
If you are planning on adding additional products to your existing line or are a start-up medical device company you need to be aware of 21 CFR 820.30 Design Control. The current thinking at the Food and Drug Administration is more in-depth inspections of the Design History File documentation (design inputs, design process, and design outputs), Device Master Record (DMR), Acceptance Criteria, Design Review Meeting minutes, verification and validation steps including Risk Analysis (ISO14197), Human Factor Studies, etc. Smith Associates has created a Step-by-Step Standard Operating Procedure to assist you in meeting the requirements of 21 CFR 820.30 from concept and feasibility to final finished product.