Documenting for Success: Best Practices in ISO 13485 Compliance

Punyamacademy04 Mar, 2024Education

Ensuring the safety and effectiveness of their products is of utmost importance for medical device manufacturers. This is where ISO 13485 comes in. This internationally recognized standard outlines the requirements for a robust Quality Management System (QMS) specifically tailored to the medical device industry. Effective documentation is a cornerstone of an ISO 13485 compliant QMS. ISO 13485 documents serve as the foundation for a structured and controlled approach to medical device development, manufacturing, and distribution.