ISO 13485:2016 is the international standard for quality management systems in the medical device industry. At Unicertifier, we help organizations implement and maintain a QMS that complies with ISO 13485:2016 standards, ensuring the safety and effectiveness of medical devices. Achieving this certification demonstrates your commitment to quality and regulatory compliance, enhancing your reputation in the healthcare sector.
Our services include gap analysis, risk assessments, and the development of quality policies and procedures specific to medical devices. We support you throughout the certification process, from documentation to internal audits and management reviews. With ISO 13485:2016 certification, you can improve product quality, reduce risks, and gain a competitive edge in the medical device market.
