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!
Sant Jordi’s Day
Saint Jordi's Day is one of the most original celebrations in Catalonia and takes place on 23 April. This popular festival combines culture and romanticism. On this day, it is custom for couples to exchange gifts...
Invasive Therapies Meeting by EHDN Invasive Therapies Working Group
Next week, our Scientific & Regulatory Affairs Associate Director Christopher Mann will be participating in the Invasive Therapies Meeting organised by European Huntington's Disease Network (EHDN) Invasive Therapies Working Group, in collaboration with SCHD (Stem cells for HD).
CAR T-cell therapy
Are you working in CAR T therapies, advanced therapies or personalised medicine and would like additional regulatory support? Please contact Asphalion at [email protected]
Brexit: Article 50 extension
On 5 April, Theresa May asked EU for Brexit extension and on 11 April, the EU agreed to a further extension of the date for the UK’s withdrawal from the EU. The extension will last as long as necessary and, in any event, no longer than 31 October 2019.
Asphalion participates at the 3rd Annual Meeting of the Myocure project
Asphalion participated in the 3rd Annual Meeting of the H2020 project MYOCURE, the 28th and 29th of March at the Ruprecht-Karls-Universität, in Heidelberg, Germany.
