The FDA requires medical device manufacturers to implement a quality management system in accordance with the Quality System Regulation (QSR) per 21 CFR Part 820. Manufacturers, specification developers, contract manufacturers, re-labelers/re-processors, and even some distributors must implement a quality management system compliant with the QSR.

Medical device manufacturers must also conduct internal audits of their quality management system in accordance with the QSR. Failure to conduct internal audits can result in product quality issues, lack of process improvements, or regulatory compliance issues. 

Medical devices can also be combined with drug products and/or biological products to create Combination Products. The products can be regulated by various divisions of the FDA [Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH)] depending on what components are in the product. Combination products must comply with the regulations outlined in 21 CFR Part 4. 

Our global team of medical device and combination product experts can assist with:

• Design History File review/audit
• Quality Systems audit 
• Design Controls audit
• Internal or vendor QSR gap analysis/audit
• Supplier audits
• FDA mock QSR/pre-inspection audit

In addition to audits, we can also provide consulting and on-site customized training. 
Click here to learn more about our medical device consulting.
Click here to learn more about our on-site customizable training.