Quality Management Systems

The implementation and maintenance of a quality management system (QMS) is a condition of registration of your medical device. Device manufacturers in Europe follow the ISO 13485 standard, while US companies comply with the US FDA’s Quality System Regulation (QSR).

If you want to sell in Europe and Canada you must be compliant with ISO13485, whilst the US has its own set of regulations known by its US regulation number 21 CFR Part 820 and FDA will require compliance to it to sell in US.

Generally international companies meet the requirements of both standards and harmonise their QMS as many other countries such as Japan, Australia and Brazil have standards based on ISO13485 and FDA QSR.

The QMS should not be viewed as a set of procedures that are only relevant when being inspected. The QMS should evolve over time and procedures should be added and amended as a company and portfolio grows in order to keep abreast of any potential product risks and data gathered from use of the product whether in development or in real world use.  This risk-based approach encourages early investigation of issues that could otherwise cause quality issues.

We can advise on building a QMS system to meet ISO13485 and 21 CFR Part 820 and also integrating a QMS within a pharmaceutical quality system. We also advise on content and can produce standard operating procedures proven to meet the requirements of the European Notified Bodies and the FDA.