Asphalion wants to be your regulatory partner for Medical Devices

medical devices

Asphalion wants to be your regulatory partner for Medical Devices

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: 

Free Webinar to guide you through the process of the Centralised Procedure
ISGlobal and CRG Career Charla

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