Medtech

Our services along the whole product lifecycle
Services by stage

Discover all our Regulatory Affairs services

Development Regulatory Affairs Market Access Vigilance Quality & Compliance Digital Health Case Studies

Due Diligence

RISK MITIGATION

Licensing or investment decision-making in tightly regulated industries like medical devices, cosmetics or pharma carry a high degree of risk.

This requires a due diligence that examines regulatory compliance across a broad spectrum of areas and stakeholders, such as manufacturers and partners, to identify risks and provide guidance on the steps forward.

Items that are typically covered include CE-mark status, clinical studies, compliance with new legislation (e.g., Regulation EU 2017/745), classification issues.

RPN’s due diligence highlights all the significant concerns and provides strategic advice.