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

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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NEWS | Proposed framework for International Recognition of Medical Devices by MHRA

This statement describes the draft policy for recognition by the UK of international regulators’ approvals of medical devices.
This statement and proposed framework applies to medical devices in Great Britain. For guidance on the regulation of devices in Northern Ireland, see Regulation of devices in Northern Ireland.

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