Richard Woortman — Regulatory Affairs

Services

Support at every regulatory step.

01

Regulatory assessment

A clear picture of where your product stands and what is needed for compliance.

02

MDR compliance

Guidance through Medical Device Regulation (EU) 2017/745, from classification to certification.

03

Technical documentation

Preparing and reviewing technical files.

04

Cosmetics compliance

Product information files (PIF), safety assessments (CPSR) and packaging and labelling advice under EU cosmetics law.

05

Research & Development assistance

Bridging between R&D results and regulatory requirements.

Let's talk about your product.

Questions about compliance or market access? Reach out directly.

Contact me