Regulatory Affairs​ for Medical Devices

Quality assurance and regulatory affairs can hardly be dissociated from each other. That’s why Quality by Design offers you the total package. We do not only take care of quality management but also support you throughout the entire drug or medical device regulatory lifecycles. Whether this concerns traditional pharmaceuticals, generics, cosmetics, vaccines, biologicals or biosimilars, medical devices or Advanced Therapy Medicinal Products (ATMP).

Expertise overview of our RA services

Our Services go from RA strategy, clinical, technical file to Vigilance.

Regulatory strategy

Global submissions

Post Market regulatory

We offer the guidance you need to navigate through complex regulatory requirements.

Lifecycle overview of our RA services

We cover all stages of the Medical Device lifecycle, we support from idea to commercialization.




ISO 13485:2016


Regulatory affairs & clinical solutions


Device manufacturing – start


Post Market Support

We offer a complete solution for your company

Our consultants offer comprehensive knowledge and expertise when it comes to regulatory affairs. We have the knowledge and expertise to support your team or to insource full regulatory affairs projects – all in an efficient and pragmatic way.

Our regulatory affairs services include writing and structuralizing registration files according to the legislation of various countries and integrating all required (technical) data.



Talk to an expert

Quality by Design offers all the experience to take care of your Regulatory affairs needs. With over 300 experts, we offer the right expertise at the right time, to support and manage your business.