Medical Device QMS, Medical Software

The current ISO 13485 standard emphasizes integrating internal processes to minimize risk within the organization. This integration includes:

• Product planning

• Corrective Actions and Preventive Actions (CAPA)

• Verification, validation, and revalidation

• Monitoring, testing, and traceability

• Risk management documentation in product realization

Another major change in the current version of ISO 13485 is regarding outsourcing. According to the new version of the ISO 13485 standard, companies that are contracted for the development, design, or servicing of medical devices must also meet ISO 13485 standards.

Quality System Regulation (QSR) or FDA 21 CFR Part 820 defines Current Good Manufacturing Practice (cGMP) regulations. Established by FDA, 21 CFR Part 820 focuses on ensuring the products meet requirements and specifications consistently. These requirements focus on the safety and effectiveness of medical devices as directed by FDA. All medical device manufacturers are mandated to undergo FDA inspections as part of FDA 21 CFR 820 compliance requirment.