The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

QMS assessors globally supported by IMC product experts, our ISO 13485 certificates are known and trusted in the medical device industry by authorities, suppliers and manufacturers around the world.

Compliance with the standard requires documenting policies for record controls, internal auditing procedures, non-conformance controls, preventative and corrective actions, process and design controls, record retention, accountability and traceability. Risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery. In the past, risk management was thought to apply only to the design and development phase, but the new standard has made it clear that it is an integral part of enterprise-wide management systems from design to post-sale.