Navigating Regulatory Compliance in Medical Device Manufacturing

At Prevailing Medical, quality has always been a priority. From the start, we implemented a Quality Management System (QMS) and achieved our ISO 13485 Certification within the first 12 months. This certification ensures we meet the necessary regulatory requirements for medical devices.

Achieving ISO 13485 Certification

ISO 13485 is an international standard for quality management systems in the medical device industry. Achieving this certification involves a comprehensive review of a company's processes and documentation. At Prevailing Medical, we were committed to quality from the beginning, which led to our quick certification.

Passing the ISO 13485 Audit

Our new facility, which we moved into in May, recently passed its ISO 13485 audit. This successful audit highlights our team's dedication to maintaining compliance with medical device regulations. Special thanks to Khader, Gordan, and Brett for leading the audit process.

The Importance of Regulatory Compliance

Regulatory compliance in medical device manufacturing is crucial for safety. At Prevailing Medical, we ensure every device meets strict regulatory standards. Our commitment to ISO 13485 compliance is evident in our daily operations and is a key part of our company culture.

Navigating regulatory compliance is essential in medical device manufacturing. Prevailing Medical's dedication to quality and adherence to ISO 13485 standards ensures we consistently meet regulatory requirements and deliver safe, effective medical devices.