The ISO 13485 standard keeps changing. Has your QMS adapted?

A medical device quality management system (QMS) is a structured system of procedures and processes covering all aspects of product design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, labeling, and more.

Gap analysis audit

We evaluate your management system to determine your current level of compliance with ISO 13485:2016. If you already have ISO 13485 certification, you are probably 80% or more compliant with the new requirements. However, it’s important to know where you stand. The gap analysis supports the development of a list of action items to adopt the new standard, also known as a quality plan.

Quality plan

The quality plan is a documented list of tasks your organization must accomplish to comply with ISO 13485:2016. In addition, there is more emphasis on quality planning in the new standard, so this is an excellent way to get started! Our consultants develop a detailed quality plan tailored to your company.

Risk-based approach

ISO 13485:2016 places much more emphasis on risk management. Our consultants evaluate your system to ensure your risk assessment and decision-making measures are as robust as possible.

Want to find out more? Contact us at or (925) 807-5100.

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