Medical Device Regulatory Services in EU and USA

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​

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