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 full package. 

Not only do we take care of quality management, but we also support you throughout the entire drug or medical device regulatory lifecycles. 

Whether this concerns traditional pharmaceuticals, generics, vaccines, biologics, biosimilars, medical devices or Advanced Therapy Medicinal Products (ATMP), we’ve got you covered.

Regulatory Affairs for Medical Devices - Quality by Design

Overview of our RA services

FROM REGULATORY STRATEGY, CLINICAL, TECHNICAL FILE TO VIGILANCE

Regulatory strategy

Global submissions

Post Market regulatory

Why QbD?

QBD'S FULL-CIRCLE SUPPORT

We cover all stages of the medical device lifecycle, from idea to commercialization.

1

Product Development
services

2

Regulatory affairs & clinical solutions

3

Product Registration Process

4

Design Transfer & Manufacturing

ISO 13485:2016

Training

A complete Regulatory Affairs solution

WE OFFER THE GUIDANCE YOU NEED

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 for medical devices include writing and structuralizing registration files according to the legislation of various countries and integrating all required (technical) data.

Contact us

TALK TO AN EXPERT

Contact us for more information or request a free, no-obligation proposal.