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Medical Device Regulatory Services in EU and USA

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We Want to Be Your Regulatory Partner for Services Associated to Medical Devices

Asphalion provides comprehensive support during development, validation, certification and manufacturing of Medical Devices (MD) and software as a medical device (SaMD) in Europe and the United States

 

Our Services for Medical Devices within Regulatory Affairs

Medical Device Regulatory Roadmaps & Feasibility Assessments

Classification Strategy & Customized Development Plans

Country Specific Medical Device Regulatory Support

  • Assistance with local Competent Authorities communication
  • Product registration
  • Other local requirements

EU Medical Device Regulations, 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 Quality Management Systems​

Conformity Assessment ​

  • Medical Device EU Certification Procedure assistance​

Assessment & Training ​

  • New EU Medical Device Regulations requirements and their impact in regulatory affairs for the medtech industry​

Medical Device Regulatory Audits​

  • Manufacturer and supplier audits​
  • QMS self-inspections​
  • Notified Body- / FDA- mock inspections​

SaMD Validation​

  • Standalone software as medical device (SaMD), Computerized Systems as part of a MD​

Validation and Qualification​

  • Medical devices manufacturing process, equipment and facilities​

​

MEDICAL DEVICES

Do you need support or more information about medical device regulatory services? Contact us!




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    Did you know that?

    • Regulatory Strategy and Scientific Advice during Development
    • Medical and Scientific Writing
    • Horizon Europe Programme | Global Regulatory Partner​
    • Global Regulatory Submissions
    • eCTD and eSubmissions
    • ISO IDMP, Data Governance Services & RIM
    • Local Support and Regulatory Affairs Service Provider in Spain
    • Local Support in the UK – BREXIT
    • Medicinal Product Life-Cycle Management Outsourcing​
    • Pharmacovigilance and Drug Safety Services
    • CMC Regulatory Solutions
    • Medical Device Regulatory Services in EU and USA
    • Advanced Therapy Medicinal Products (ATMPs) & Biologics

    ASPHALION S.L.

    HQ – Barcelona
    info@asphalion.com
    +34 93 238 5945

    Munich Office
    munich@asphalion.com
    +49 (0)89 039 280

    Madrid Office
    madrid@asphalion.com
    +34 910 483 817

    London Office

    london@asphalion.com

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