The MDR application date is here – Are you ready?
The EU Medical Device Regulation (MDR) EU 2017/745 applies to MedTech companies but also companies within pharma, biotech and cosmetics who market e.g., combination products and aesthetics which are similar to medical devices in functioning and risk-profile but without an intended medical purpose.
Are you on top of the changes and aware of what demands that are applicable for your company?
Devicia is a full-service partner offering regulatory and clinical expertise for medical devices, including:
– MDR transfer strategy
– Medical Writing ranging from Clinical Evaluations to Scientific Publications and Medical Marketing
– Full-service Clinical Investigation Consultancy
– Regulatory Affairs
– Through our partner network, we can provide you with compilation of technical documentation, the implementation and/or upgrade of Quality Management System in compliance with the MDR and expertise within Biological Evaluations.
Don’t hesitate to contact us if you need guidance or if you have any questions.
Our advice is always founded on our vast experience and our participation in technical committees – with us, you get the inside perspective.