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MDR (EU) 2017/745: KEY SOLUTIONS PROVIDED BY ASPHALION

ASPHALION experts will help you make sure your device complies with the new MDR requirements.

ASPHALION experts will help you make sure your device complies with the new MDR requirements.
May 28, 2021
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  1. GAP ANALYSIS OF MDD-BASED TECHNICAL DOCUMENTATION AND QUALITY MANAGEMENT SYSTEM TO ALIGN WITH MDR REQUIREMENTS
  2. WRITING AND REVIEW SUPPORT TO IMPLEMENT ANY NECESSARY CHANGES IN TECHNICAL DOCUMENTATION OR QMS PROCEDURES
  3. SUPPORT IN CLINICAL EVALUATION PLANS AND REPORTS, POSTMARKET CLINICAL FOLLOW-UP PLANS AND REPORTS
  4. SUPPORT IN POSTMARKET SURVEILLANCE PLANS AND REPORTS
  5. STRATEGIC SUPPORT TO DEFINE A COMPLIANCE ACTION PLAN REGARDING DEADLINES AND GRACE PERIODS
  6. SUPPORT IN EUDAMED REGISTRATION
  7. SUPPORT IN COMPLIANCE ACTIVITITIES AND MAINTENANCE OF CE CERTIFICATIONS
  8. TRAINING

➕ AND MORE…

DOES YOUR DEVICE COMPLY WITH MEDICAL DEVICE REGULATION (EU) 2017/745)?

ASPHALION experts will help you make sure your device complies with the new MDR requirements.

➡️ You can also contact us at: [email protected]

We will be more than happy to help you!

 

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