Regulatory Monitoring and Compliance Support
Ongoing monitoring of regulatory updates is crucial to ensure that medical devices and in vitro diagnostic devices remain compliant with continuously evolving legal requirements.
With the frequent changes to standards and regulations — particularly under the MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) — it is essential for companies to maintain active surveillance over updates that may impact their operations.
We offer a continuous regulatory monitoring service, combined with tailored support to help adapt your products and internal processes, ensuring ongoing compliance with the latest requirements.
Our services include
Regular tracking
Regular tracking of legislative updates at both European and national levels, including new regulations, directives, and technical guidance
Impact analysis
Impact analysis of regulatory changes, identifying which updates directly affect your devices
Support in adapting technical documentation
Support in adapting technical documentation and internal processes to maintain compliance
Notification and management of significant changes
Notification and management of significant changes to ensure continued product conformity throughout its lifecycle
Consulting
Consultancy on ongoing compliance strategies, including post-market surveillance (PMS/PMCF) planning and risk management
This service is essential for:
Products up to date
Manufacturers and distributors seeking to ensure their products remain up to date and compliant with applicable regulations
Adjust products and strategies
Growing companies that require support to adjust their products and strategies as standards and market expectations evolve
Mitigate non-compliance risks
Organisations aiming to mitigate non-compliance risks in a dynamic regulatory environment
With our support, you can
Regulatory updates
Your products remain aligned with the latest regulatory updates
Avoid legal and financial risks
You avoid legal and financial risks associated with non-compliance
Internal processes are efficiently adapted
Your internal processes are efficiently adapted with minimal disruption to business operations
