No matter what type of product you create, you must have a controlled process to document, design, test, produce, and ship medical device products in the United States as stipulated by the FDA Title 21 CFR Part 820. Companies that wish to sell outside the U.S. need to also comply with ISO 13485. In fact, the FDA has agreed to use ISO 13485 as the basis for its quality system regulation as well.
Managing the quality and compliance processes in context to the entire product record enables a product-centric QMS approach. This keeps internal and external teams on the same page and accelerates design reviews, corrective actions, and resolution. Productcentric QMS provides better visibility, traceability, and control in these areas:
- Product record and bill of materials (BOM)
- Component compliance information
- Device master records (DMR)
- Design history files (DHF)
- Corrective action requests (CAPA)
- Design reviews
- Engineering change orders (ECO)
- Validation and verification records
- Training records
- Approved manufacturers and suppliers (AML/ASL)
Many traditional QMS solutions provide a document-centric approach, but these solutions must manage more than just documents. QMS applications must manage the complex product record and hierarchal BOM with links from every component and document to every associated quality and product record. This provides full context among the design, quality, and manufacturing teams, as well as greater access and traceability between disparate teams that engage throughout the development and commercialization process. And because this information is controlled in a single system, internal and external auditors can quickly and easily verify compliance.