Our team provide comprehensive support during development, validation, certification and manufacturing of Medical Devices (MD) in Europe and the United States.
Asphalion can support you in:
- Regulatory Roadmaps & Feasibility Assessments
- Classification Strategy & Customized Development Plans
- Country Specific Regulatory Support
- MD EU Technical File revision, compilation and 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
If you need any support or have any further question, please contact us at [email protected]
More information: https://www.asphalion.com/services/medical-devices/