MEDICAL DEVICE REGULATION (EU) 2017/745 (MDR) | KEY SOLUTIONS PROVIDED BY ASPHALION

MEDICAL DEVICE REGULATION (EU) 2017/745 (MDR) | KEY SOLUTIONS PROVIDED BY ASPHALION

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

➑ 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.

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 :

https://services.asphalion.com/medical-devices-regulation

☑️ 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:

https://outlook.office365.com/owa/calendar/AsphalionSL@asphalion.onmicrosoft.com/bookings/

➡️ You can also contact us at: info@asphalion.com

We will be more than happy to help you!

 

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