- GAP ANALYSIS OF MDD-BASED TECHNICAL DOCUMENTATION AND QUALITY MANAGEMENT SYSTEM TO ALIGN WITH MDR REQUIREMENTS
- WRITING AND REVIEW SUPPORT TO IMPLEMENT ANY NECESSARY CHANGES IN TECHNICAL DOCUMENTATION OR QMS PROCEDURES
- SUPPORT IN CLINICAL EVALUATION PLANS AND REPORTS, POSTMARKET CLINICAL FOLLOW-UP PLANS AND REPORTS
- SUPPORT IN POSTMARKET SURVEILLANCE PLANS AND REPORTS
- STRATEGIC SUPPORT TO DEFINE A COMPLIANCE ACTION PLAN REGARDING DEADLINES AND GRACE PERIODS
- SUPPORT IN EUDAMED REGISTRATION
- SUPPORT IN COMPLIANCE ACTIVITITIES AND MAINTENANCE OF CE CERTIFICATIONS
- 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!