• MDR - Medical Device Regulation 

    The European regulations requires that manufacturers monitor the performance and safety of their devices through ongoing assessments.

    It is critical to stay up-to-date with regulations and be supported in the recertification of medical devices.

How does MDR works?

MDR, short for Medical Device Regulation, is a set of laws developed by the European Union (EU) to ensure the safety and efficacy of medical devices available in EU countries. It covers all stages of the production chain - from design to manufacture and marketing. The purpose of MDR is to improve patient safety by ensuring that medical devices are of high quality, effective and reliable.

The Medical Device Regulation requires manufacturers to implement a systematic and ongoing process of post-market surveillance. This includes:

  • monitoring the performance of the product
  • collecting feedback from customers
  • conducting studies
  • analyzing any potential safety or performance issues.

Such updates are essential in order to maintain compliance with all relevant regulations and standards over time.


Recertification and Post-Market Surveillance

Medical device manufacturers today face significant challenges in complying with the stringent Medical Device Regulation requirements. This can be a costly and time-consuming endeavor, leaving little room for innovation or patient care.

Non-compliance with Medical Device Regulation can lead to costly fines and cause serious damage to a company’s reputation.

EndoCore Lab provides:
  • comprehensive recertification support
  • clinical studies for post-market surveillance

Thanks to these services we can help our partners quickly meet all regulatory requirements in an effective and cost-efficient way.

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