OUR MDR/fDA ADDED VALUE

Our MDR added value

The MDR has ushered in more stringent standards for medical devices in Europe, focusing on safety, quality, and performance. It classifies devices based on their risk profile and imposes stricter conformity requirements for higher-risk classes. Manufacturers are now required to provide extensive pre-market clinical evidence and demonstrate conformity to essential requirements, overseen by notified bodies

Navigating this transition successfully is crucial to prevent the risk of medical device rejection. Choosing the right regulatory assurance advisor is key to ensuring a smooth process tailored to your needs.

At GMRE, we are dedicated to your success and offer added value through our expertise in various areas:

Our MDR services include:

  • MDR transition strategies
  • Gap Analysis
  • Notified Body selection support
  • Technical Documentation preparation
  • Clinical Evaluation Reports
  • SSCP(Summary of Safety and Clinical Performance)
  • Risk Management Files
  • Biological Evaluation Reports
  • Verification and Validation activities
  • Packaging and Sterilization validation
  • PMS, PMCF and PSUR preparation
  • MDR Article 10(9) Quality System
  • UDI and EUDAMED requirements

Regulatory Project Management.

Partner with GMRE to benefit from our added value services and ensure a seamless transition to compliance with MDR regulations

Our FDA added value

FDA Regulatory Services

GMRE provides:

  • FDA 510(k) submissions
  • eSTAR preparation and submission
  • Regulatory Strategy
  • Predicate Device Analysis
  • Design Controls
  • DHF preparation
  • Risk Management
  • Verification & Validation leading
  • FDA readiness assessments
  • QMSR -Quality Management Systems Regulations
  • Global Regulatory Strategy.

 

Skip to content