Smith Associates has developed implementation-ready Part 820 Quality Systems which includes SOPs with supporting logs and forms. The QS Part 820 is priced reasonably to meet quality system requirements from start-ups in the design phase to the small or large company, with Class I, II or III products. The SOPS, forms, WIs and Quality Manual have been reviewed by the FDA during inspections all over the United States and internationally, and will assist you in maintaining a stable and compliant FDA 820 cGMP System.

Quality System SOPs for Product Development Under Design Control

Quality System begins with a Design Review meeting in order to leave the design concept and feasibility phase.

Your medical product must be developed according to Part 820.30 Design Control. Once you are ready to leave Design Feasibility/Concept Phase make sure you have your complete Design Control Quality System reviewed, approved and implemented. The paperwork generated under Design Control will provide the necessary test reports and labeling information required for your 510(k) and the Design History File and DMR will be readily available for an FDA Inspection.

FDA expects your company to manufacture your device or IVD with a fully implemented and working quality system prior to marketing your medical device. The number one problem we have found is formal Design Review meetings were not held or documented between the various design and development stages.

We can supply you with implementation ready standard operating procedures and forms to meet the requirements of 820.180 and 820.198. All you need to do is review, approve and implement.

Quality System 820 SOPs for ISO 13485 Gaps

Most of the medical device manufactures around the globe have implemented ISO 13485 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes and so have thousands of medical device companies in the United States who market their medical devices outside the United States.

We spend a good portion of each year attending FDA Inspections of our clients. Over the past three years I have noticed the FDA focusing their attention on Design Control activities, such as design history files (DHF), device master records (DMR), device history record (DHR), complaint handling and medical device reporting, etc. Many of these topics sound similar between the ISO 13485 and Part 820 Quality Systems but they are not. Smith Associates knows the differences between the two Quality Systems and can provide standard operating procedures, logs and forms that cover the needs of both the ISO and FDA Quality System’s requirements. The only task you need to perform is review, approve and implement and the differences between the two systems disappear.


Quality System SOPs for the Start-Up, Medium or Large Medical Device Companies with Pricing to Fit Your Needs

Many medical device companies are small to medium size with fewer than 50 employees and have limited personnel to act as a Quality System Manager. However, FDA still requires the manufacturer to maintain a Quality System which meets all the requirements of Part 820 of the Code of Federal Regulations.

Smith Associates was formed in January 1994 to help small and medium size medical device firms achieve FDA clearances without breaking their financial backs. When your firm receives the FDA clearance letter the third paragraph states the following:

“Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.”

This means you need to be manufacturing your medical device under a quality system in order to be compliant with the applicable Codes of Federal Regulations.

Smith Associates can offer you a COMPLETE Quality System that fulfills all of the requirements of 21 CFR 820. All you have to do is review, approve and implement the quality system. We offer two quality systems, 1) start-up or very small manufacturers and 2) medium to large medical device manufacturers. We also supply support and training if necessary.

Quality System SOPs for the Specification Developer

Since I am not manufacturing the product do I still need a quality system? Yes, you still need a Quality System.

Even though you have subcontracted many of these responsibilities to another company, the FDA inspector would still expect to see original engineering drawings, design history files, device master records, device history files, records of all nonconforming products, complaints, medical device reports, etc. to be available at the Specification Developer’s place of business. The FDA holds the 510(k) Owner/Sponsor responsible for all quality system activities whether at your place of business or your subcontractor’s place of business to insure that the product they cleared is the product being produced and sold in the United States.

In conclusion you need to make sure you have a strong quality system in place in order to pass FDA Inspections.

Quality System SOPs for the Initial Importer

If I am an Initial Importer do I need a Quality System?
The answer to that is a yes, but only parts that are assigned to you by the manufacturer.

If you are an initial importer your contract should specify what quality system duties have been subcontracted to your firm. Find out what Code of Federal Regulation you are responsible for and Smith Associates can supply you with the correct SOP, Work Instruction or form to meet your needs. All you have to do is review, approve and implement.

Implementation and Training of the Quality System can be provided upon request, either online or on-site.