Regulatory & Safety

genae provides a full range of regulatory support services for your pre- and post-marketing medical device development needs. Our experts adopt best practices while remaining on top of the ever-changing regulatory landscape, meeting current demands in the following areas:

Regulatory Consulting
  • Regulatory Go-to-Market Strategy for Medical Devices in the EU and the U.S.
  • European Medical Device Classification
  • Clinical Evaluation Report Compilation and Consulting
  • CE Mark Consulting
  • EU Medical Device Market Regulatory Overview Report


In-country representation

  • Legal Representation
  • EC Authorized Representation

Regulatory submissions
  • Ethical Committee and Site-level IRB submission support
  • FDA, European Competent Authorities and other country-specific review boards

Reimbursement
  • European Medical Device Reimbursement Consulting

Clinical Safety 
  • Safety Management Plan creation/review
  • Adverse Event Management
  • Preparation of Regulatory Reports
  • Expedited and periodic reporting
  • Regulatory Compliance Tracking
  • Data Safety Monitoring Board (DSMB) and Clinical Event Committees (CEC) services

Post-Marketing Surveillance (PMS)
  • Medical Device Vigilance system creation and maintenance
  • Incident reporting
  • Literature and Media Publications Review
  • Customer Experience Reporting Process facilitation
  • Post-Market Clinical Follow-up Studies

Regulatory Medical Writing and Medical Communication
  • Benefit Risk Assessment Report
  • Case Report Form
  • Clinical Development Plan
  • Clinical Study Report
  • Clinical Trial Protocol
  • Informed Consent Form
  • Investigator Brochure
  • Investigator Newsletter
  • Literature Summary
  • Manuscript
  • Narratives
  • Risk Management Plan
  • White Paper



Download a free copy of our white paper 'The road to a successful medical device launch', which guides you through the most important regulatory steps in successfully launching a medical device.
 

I appreciated the communication and regular follow-up of the regulatory team at genae. I was able to understand the competent authority process in each country, and genae helped me to stay compliant with the changing regulations.
 

Yoni Ben-Zvi

VP R&D Mitralix, Israel

9-2300
Enrolling / enrolled subjects
 

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