FAQ

ISO 13485 is an internationally recognized standard for quality management systems specific to the medical device industry. It ensures that companies meet regulatory requirements and maintain high standards of quality and safety in the production of medical devices.

A consultant can provide expertise in developing and implementing quality management systems compliant with ISO 13485 requirements. They offer guidance on documentation, process optimization, and training to ensure successful certification.

Certification demonstrates a commitment to quality, enhances market credibility, facilitates access to international markets, reduces risks of product recalls or regulatory penalties, and improves overall operational efficiency.

A gap assessment involves a thorough review of a company's existing quality management system against ISO 13485 requirements to identify areas of non-compliance or improvement. This assessment serves as a roadmap for achieving certification.