About
Casus Consulting offers regulatory affairs and authorized representative services specifically for the EU, UK, and Switzerland. They provide guidance on various medical device regulations, including the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Key services include navigating post-market surveillance requirements, clinical evaluation plans, and market entry strategies for medical devices across different jurisdictions. Clients can benefit from comprehensive resources, including step-by-step guides for registering medical devices with the UK MHRA, understanding risk management concepts under ISO 14971, and preparing for audits. Their expertise is pivotal for manufacturers aiming to comply with varying regional regulations.
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