ISO 13485 is the medical industry’s optimal device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.
Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.
Requirements of ISO 13485
- Documentation requirements for medical device files
- Production requirements for cleanliness of products
- Work environment requirements
- Production requirements for sterile medical devices
- Contamination control requirements
- Requirements for reporting to regulatory authorities
Benefits of ISO 13485
- Ability to contract with larger companies
- A defined process for effective risk analysis
- Demonstrate commitment to high quality
- Help staff access relevant Information
- Expand potential market
- Meet the complete product requirement by the customers
