EU Medical Device Regulation (MDR) | MDV-Solve
About MDR Compliance
The Medical Device Regulation (EU) 2017/745 (MDR) establishes a modern, robust and transparent regulatory framework for medical devices. It ensures a high level of health and safety while supporting innovation.
Our MDR compliance services include:
- Gap analysis between MDD and MDR requirements
- Technical documentation preparation and review
- Classification guidance under MDR Annex VIII
- Clinical evaluation and PMCF planning
- Unique Device Identification (UDI) implementation
- EUDAMED registration support
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MDSAP Program
The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a …
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Establish and implement an effective tailored cGMP system in line with requirements.
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Implementation of process validation system including IQ, OQ, and PQ qualifications.
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