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!
Summer – Asphalion does not close in August!
We will be open in August and available to attend all your needs and requests as usual!
2 clicks for a free 30-minute meeting!
Do you need regulatory support during your drug development? It has never been so simple to get it!
Craash Barcelona | Regulatory Aspects for Medical Devices by Dominique Monferrer
Dominique Monferrer, Asphalion’s Medical Devices Expert, was invited to give a talk on Regulatory Aspects for Medical Devices to participants of the 3rd edition of Craash Barcelona program.
Are you thinking of implementing a RIM System?
Don’t you know how IDMP can affect the way you store your data? Do you need more information? Schedule a meeting with us!
EAEU electronic format – Mandatory
On the 3rd of August 2017, the Committee of the Eurasian Economic Union (EAEU) released the standards for EAEU electronic submissions.
