It is critical for medical device manufacturers and suppliers to begin implementing the standards of the revised ISO 13485:2016, as the allotted three-year changeover period may not provide adequate time for all organizations to transition. Under the new standard, global device companies are required to conform to country specific regulatory requirements for each jurisdiction where the product is sold. Additionally, the regulation includes a provision for “strengthening of supplier controls” which requires device manufacturers to ensure all supplier quality-related processes fully comply with the requirement. ISO 13485 will ultimately act as a tool for companies to effectively plan, monitor and improve overall quality management and must be a top priority for manufacturers looking to maintain compliant certifications.
- Understanding the scope of certification and key guidance changes
- Real-world timelines for transitioning all certifications
- Implications for supplier management and controls
- New requirements for adequate training and education
Kimberly A. Trautman
Executive Vice President, Medical Device International Services
NSF Health Sciences, a division of NSF International