Regulatory Affairs

Finding your way through the regulatory landscape can be difficult as it requires up-to-date knowledge, experience and contacts. Our strategic consulting team guides you along the most efficient and optimal strategic path to CE-mark, device registration and/or approval outside EU and support in building up and use post market surveillance.

Regulatory Services

  • Classification and Regulatory Strategy with reference to the Intended Use and Commercial Markets
  • Project Definition
  • Risk Management
  • Build up Design History File and Summary of Technical Documentation (STED) with all aspects of the Technical File
  • Support in selection and handling of materials and in preparation of Biological and Clinical evaluations based on literature studies

Submissions, Notified Bodies and Regulatory Authorities

We take care of device approval submission, maintain efficient contact with Notified Bodies and relevant Regulatory Authorities.

Post Market Surveillance

We take care of vigilance, post market clinical follow-up and update of the technical file.

Global Regulatory Community

Our consulting team has an in-depth knowledge of regulatory systems world-wide. Combined with our knowledge of the notified bodies and regulatory authorities, this means that we can help you with device registration and/or approvals quickly and efficiently.

Contact us to find out more about Regulatory Affairs

Project Stages

Exploratory/Research Project Definition

What Happens:
  • Initial Market Research: Is there a Market?
  • Actual Potential Market Validation: Where and how to position the device?
  • Commerical Due Diligence: Provide commercial answers to investors
  • Project Risk Research
  • Regulatory and Clinical Research
  • Reimbursement Analysis

R&D:
  • Device Design Research

Documentation:
  • Initial Market Report
  • Commercial Due Diligence
  • Project Specification
  • Initial Regulatory Strategy
  • Reimbursement Analysis

- MILESTONE ACHIEVED -

Project Development

What Happens:
  • Device Concept Development

R&D:
  • Prototype Development
  • Material Evaluation

Documentation:
  • Design Requirements
  • Initial Clinical Literature Survey
  • Initial Material Survey
  • Regulatory and Clinical Strategy
  • Risk Analysis
  • Reimbursement Analysis

- MILESTONE ACHIEVED -

Design Verification and Freeze

What Happens:
  • Clinical Study set-up
  • Determine Clinical and Economic evidence needed
  • Risk Analysis
  • Final Product Development

Services:
  • Verification Tests
  • Biocompatibility Tests
  • Animal Tests
  • Prototype Production
  • Commercial Strategy

Documentation:
  • Verification and Validation Plan
  • Risk Analysis
  • Biological Evaluation
  • Clinical Evaluation
  • Device Specifications
  • Reimbursement Analysis
  • Budget Impact Model tools

- MILESTONE ACHIEVED -

Clinical Trial and Validation

What Happens:
  • Risk Analysis
  • Clinical Trial Start-up

Services:
  • Pilot Production
  • Clinical Trials
  • Product and Process Validation
  • Commercial Strategy

Documentation:
  • STED/Technical File
  • Validation Reports
  • Interim Clinical Trial Report
  • Reimbursement Analysis
  • Budget Impact Model Tools

- MILESTONE ACHIEVED -

Product Release and Market Surveillance

What Happens:
  • Regulatory Approval
  • Clinical Trial Follow-up
  • Marketing
  • Sales

Services:
  • CE Mark
  • Product Registration
  • Post Market Surveillance
  • Commercial Execution
  • Market Growth

Documentation:
  • Clinical Trial
  • Final Report
  • Vigilance Reports
  • Market Approval Letters
  • Budget Impact Model Tools

- MILESTONE ACHIEVED -