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!
SME Office – Annual Report 2018
he SME Office has published its annual report summarising its experience with small and medium-sized enterprises (SMEs) during the year 2018.
Bases de datos de Farmacovigilancia: ¿qué debe saber IT?
Si necesitas saber qué tipos de bases de datos existen para Farmacovigilancia y cómo garantizar las seguridad, integridad y trazabilidad de los datos, no pierdas nuestro próximo webinar que tendrá lugar el día 28 de Junio de 11-12 horas.
Are you ready to enter the transformed landscape in Pharmacovigilance?
On 12 & 13 June, Sónia Lopez, Qualified Person Responsible for Pharmacovigilance at Asphalion, and Núria Cabello, Senior Drug Safety Officer at Asphalion, will be participating in the International Pharmacovigilance Day conference organized by LS Academy.
Drug Device Combinations: Consultation on draft guideline on quality requirements
On 03.06.2019 the European Medicines Agency released a draft guideline on the quality requirements for medical devices (MD) in human medicines that include a MD for a 3-month public consultation, as part of a series related to the European’s medical devices regulation.
