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