Regulatory
Consulting

__________

Regulatory
Consulting

Background

Regulatory compliance is a key ingredient to your success story in most industries and jurisdictions around the world, and this is especially true for medical devices and in-vitro diagnostics (IVDs) being placed on the EU and UK markets. The heavy regulation of these products has increased in recent years, with the EU Medical Device Regulation 2017/745 (MDR) and EU IVD Regulation 2017/746 (IVDR) setting a high standard for compliance. However, meeting these requirements and obligations does not need to be such a drain on your resources.

Services

Our team offers a host of services to help you meet your regulatory goals in both the EU and UK, and maintain compliance throughout the whole product lifecycle. Whether contracted at the design stage or in the post-market phase, we will work with and guide you over the regulatory hurdles, and across the finish line. Select any of the below services for further information.

Better still, get in touch with us today and we can discuss which service is the right fit for you and your product.

Technical Documentation

Compliant technical documentation for EU and UK jurisdictions.

Gap Assessment

In-depth compliance assessments of your existing documentation.

Device Qualification & Classification​

Detailed reports qualifying and classifying your devices.

General Consulting​

We provide accurate consulting services on all regulatory subjects.

Regulatory Strategy​

An expertly drafted strategy to ensure your success in the EU and UK.

Label & IFU Consulting

Review and consultation on information being provided with your devices.

Simplify your compliance workflow.