MEDICAL DEVICE REGULATORY CONSULTING

Does your device comply with
Medical Device Regulation
(EU) 2017/745 (MDR)?

Asphalion provides comprehensive regulatory support during development, validation, certification and maintenance of Medical Devices (MD).

WHAT WE DO

Our expert team will help you
with medical device regulation of:

Wearables, IVDS & Biomarkers 

Substance-based and borderline products

Drug device
combination

Digital health solutions: medical device software

Gap analysis of available technical documentation and quality management system to align with MDR requirements

SERVICES

Our key Medical Device Regulation services   

According to the recent change in the Medical Devices Regulation, Asphalion experts are offering a series of key solutions to support you over the whole life-cycle of your medical device. 

Writing and reviewing support to implement any necessary changes in technical documentation or QMS procedures

Support in clinical evaluation plans and reports, post-market clinical follow-up plans and reports

Support in post-market surveillance plans and reports

Strategic support to define a compliance action plan to meet deadlines and grace periods

Adaptation of your quality management system 

Support in EUDAMED registration 

Support in compliance activities and maintenance of CE certifications

Training

THE PROCESS

Whole life-cycle support

Our team of experts supports you over the whole life-cycle of your medical device, from its initial conception to CE marking and beyond post-commercialisation. 

01

Early 

Development

Regulatory strategy, feasibility assessment, classification analysis.  

02

Design & 
development

Risk management, Testing and verification study plans, Pre-clinical and Clinical, Development plans.

03

CE marking &
placing on the market

TD acc MDR, Management with NBs, non-conformities, UDI, EUDAMED.

04

Post-Market
duties

PMS Reports, Incident Management, PMCF reports. 

05

Maintenance

Risk management update, QMS audits, Technical vigilance, Trainings. 

ABOUT ASPHALION

Why work with us?

20+ years experience

Asphalion is a team of senior experts with 20+ years of experience in Medical Device Regulations.

200+ Medical Device projects

Including development, CE marking and maintenance.

Tight timelines

Thanks to our expertise, our team is able to manage tight timelines and critical submissions.

CONTACT US

Get ready for the new Medical Device Regulation

"Comply with the new Medical Device Regulation with our advice. Contact us now and an expert will get back to you."

Dominique Monferrer

Regulatory Affairs Director Medical Devices

info@asphalion.com

+34 931851377

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