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!
Digital transformation and pharmacovigilance: technology update
Today, our experts Núria Romero, Sonia López, Nuria Cabello and Bernat Autonell participated in the workshop “Digital transformation and pharmacovigilance: technology update” organized by Arithmos, Asphalion and Oracle Health Sciences.
Marcos Fernandez is attending the LORENZ userBridge Conference 2019
Today Marcos Fernandez, Regulatory Affairs Manager at Asphalion, is attending the LORENZ userBridge Conference 2019 in Greece.
Luxturna: the first licensed gene therapy for rare inherited eye disorder is recommended by NICE
A draft NICE guidance recommends Voretigene Neparvovec (also called Luxturna) to treat people with vision loss caused by inherited retinal dystrophy from confirmed RPE65 gene mutations who have enough viable retinal cells.
FDA aims to start deactivating outdated drug listing records to ensure the patient safety
The Food and Drug Administration (FDA) announced its intention to clean the drug listing database from outdated and uncertified records.
New study shows EMA and FDA aligned on marketing authorisations
The FDA and the EMA are aligned in more than 90% of marketing authorizations (MA) for new drugs, according to a new study from EMA and FDA officials comparing 107 new medicine applications at the two agencies between 2014 and 2016.
