ISO 13485 is an international standard that outlines the requirements for a quality management system (QMS) for medical device manufacturers. The standard was first introduced in 1996 and has since been revised in 2003, 2016, and most recently in 2021. ISO 13485 is used by medical device companies worldwide to ensure that their products are safe and effective, and meet regulatory requirements.

The standard provides a framework for the development, implementation, and maintenance of a QMS that is specific to the medical device industry. ISO 13485 covers all aspects of the medical device lifecycle, from design and development to production, installation, and servicing. It also includes requirements for post-market surveillance, risk management, and documentation.

One of the key features of ISO 13485 is its focus on risk management. The standard requires companies to identify, assess, and mitigate risks associated with their medical devices throughout their lifecycle. This includes risks related to product design, production, and use, as well as risks associated with the supply chain and distribution.

ISO 13485 also requires companies to have a comprehensive quality manual that outlines their quality policies and procedures. The quality manual must be regularly reviewed and updated to ensure that it remains relevant and effective.

Many companies are in the process of upgrading their management systems to include Medical Device certifications. Registration to these Standards is the key to diversifying your client base.

Management Solutions Group, Inc. has been in the forefront of this effort to provide our clients with assistance in training and implementation. We hope that the following information will be useful as you explore new opportunities in the medical device industry.

This standard is based on ISO 9001:2008.  Therefore companies that have a strong ISO 9001 or IATF 16949 system will find that they have many of the required processes in place. They will still, however, need to address the requirements specific to the medical device industry as required in ISO 13485. We will highlight some of the additional and specific requirements here.