➊ GAP ANALYSIS OF MDD-BASED TECHNICAL DOCUMENTATION AND QUALITY MANAGEMENT SYSTEM TO ALIGN WITH MDR REQUIREMENTS
➋ WRITING AND REVIEW SUPPORT TO IMPLEMENT ANY NECESSARY CHANGES IN TECHNICAL DOCUMENTATION OR QMS PROCEDURES
➌ SUPPORT IN CLINICAL EVALUATION PLANS AND REPORTS, POSTMARKET CLINICAL FOLLOW-UP PLANS AND REPORTS
➍ SUPPORT IN POSTMARKET SURVEILLANCE PLANS AND REPORTS
➎ STRATEGIC SUPPORT TO DEFINE A COMPLIANCE ACTION PLAN REGARDING DEADLINES AND GRACE PERIODS
➏ SUPPORT IN EUDAMED REGISTRATION
➐ SUPPORT IN COMPLIANCE ACTIVITITIES AND MAINTENANCE OF CE CERTIFICATIONS
➕ 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.
Asphalion’s regulatory support covers the whole life-cycle of a medical device, from its initial conception to CE marking and beyond post- commercialization:
🔑 MDR key changes decalogue :
☑️ Also, in case you would like to know more or need further assistance, you can schedule a free 30 minutes consultation meeting at the Medical Devices calendar here:
➡️ You can also contact us at: email@example.com
We will be more than happy to help you!