Quality Assurance and Regulatory Affairs

With our support, you can ensure that your products meet regulatory requirements from the EU and The United States and others, leading to faster market access and minimized regulatory risks. MCC team have in-depth knowledge of regulations such as MDR, FDA 21 CFR Part 820, and standards (e.g. ISO 14971, ISO 13485) which means that we can guide you through the entire product lifecycle, from product development of concept to market approval.

We understand that every product and market is unique. That's why we offer flexible and tailor-made Solutions that ensure you're always at the forefront of compliance.

To develop a medical device, the journey begins with a functioning QMS.

We can help with a GAP analysis of your QMS (quality management system) to get a status of  your compliance towards your QMS and actual MPA`s. MMC can perform a GAP analysis of your product technical documentation to determine compliance.

Quality Managment System

MMC can help you build a complete QMS or help in improving your QMS to a point where its compliant. 

We have experience of building/improving QMS for very small companies with few headcounts to very large companies.

Some common regulations and standards that needs to be taken into account are:

- MDD Medical Device Directive 93/42/EEC

- MDR Medical Device Regulation (EU) 2017/745

- FDA 21 CFR Part 820

- ISO 13485:2016 Quality management system

- ISO 9001:2015 Quality Management System

- ISO 14971:2019 Application of a risk management system

- SS-EN ISO 20417 Information to be provided by the manufacturer

- IEC 62366-1:2015 User-friendliness of medical devices

- ISO 15223-1:2016 Symbols to be used with medical device

- SS-EN ISO 14155:2020 Clinical trials on medical devices – Good clinical practice

- SS-EN ISO 10993-1:2020 Biological evaluation of medical devices

- SS-EN 60601 Electrical equipment for medical use