We want to be your regulatory partner for medical devices
Asphalion provides comprehensive support during development, validation, certification and manufacturing of Medical Devices (MD) in Europe and the United States
- Regulatory Roadmaps & Feasibility Assessments
- Classification Strategy & Customized Development Plans
- Country Specific Regulatory Support
Assistance with local Competent Authorities communication
Product registration
Other local requirements
- MD EU Technical File revision, compilation and maintenance
General Safety and Performance Requirements
Risk Analysis
Clinical Evaluation Reports
Pre-Clinical Testing Reports
Instructions for use and Labelling
Post-Market Surveillance Plans and Reports
other Technical File core-parts revision / compilation / maintenance
- Quality Management System (QMS) design and implementation based on ISO 13485 and 21CFR 820
- Conformity Assessment – Medical Device EU Certification Procedure assistance
- Assessment & Training on the new EU Medical Device Regulations requirements and their regulatory impact for the medtech industry
- Audits
Manufacturer and supplier audits
QMS self-inspections
Notified Body- / FDA- mock inspections
- Software Validation – Standalone software as medical device (SaMD), Computerized Systems as part of a MD
- Validation and Qualification of the MD manufacturing process, equipment and facilities
Do you need support or more information about the services? Contact us!
Updated version of the document “EMA post-authorisation procedural advice for users of the centralised procedure”
Last week, European Medicines Agency (EMA) updated the guidance document “European Medicines Agency post-authorisation procedural advice for users of the centralised procedure".
New regulation to ease the renewal of the designation of NBs and prevent shortages of MDs in the EU
The European Commission (EC) has published a Commission Implementing Regulation to ease the renewal of the designation of notified bodies (NBs) and prevent shortages of medical devices (MDs) in the European Union (EU).
Commission Implementing Decision C(2020) 2532
The European Commission (EC) has published a Commission Implementing Decision requesting a review (standardisation) of a set of existing standards, as well as new standards to be drafted, for support of Regulations 2017/745 (MDR) and 2017/746 (IVDR).
Asphalion is proud to be sponsor of the Online Strategy Meeting on CMC & Regulatory Affairs!
Asphalion will participate in the Online Strategy Meeting on CMC & Regulatory Affairs. Our RIM and data management expert, Marcos Fernández will provide a presentation on IDMP and the impact in regulatory affairs.
WEBINAR | MDR postponed: an opportunity that cannot be missed
Dominique Monferrer, one of our medical devices expert, held this free webinar on the postponement of the MDR, with an analysis of its impact and potential opportunities for the sector.
