Safety and quality are non-negotiable in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.

ISO 13485 Certification Ensure confidence in medical device safety. ISO 13485 will help organization do business in this highly regulated sector.

Whether organizations are looking to operate internationally or to expand locally to accommodate new business, ISO 13485 will help demonstrate to customers and regulators that they are committed to quality.

The regular assessment process will ensure that processes are continually checked for effectiveness and provide the opportunity to avoid unpleasant regulatory surprises. Certification to this standard can improve overall performance, remove uncertainty and widen market opportunities with complying to requirements, such as

  • Basic Quality System requirements with several enhancements
  • Risk Management Approach to product development and product realization
  • Validation of processes
  • Consideration of statutory and regulatory requirements