Design Control & Technical Documentation

I support Medical Device and IVD organisations with Design Control activities and preparation of Technical Documentation.

My consulting experience includes assignments performed both as part of R&D organisations and within Quality functions. I therefore have hands-on experience with both preparation of design and development documentation and Quality- and Compliance-related activities within development projects.

Areas of Support

I can support organisations with:

  • Design and Development Planning
  • Design Inputs and Outputs
  • Design Reviews
  • Design Verification and Validation documentation
  • Design Changes
  • Design Transfer activities
  • Preparation and improvement of Technical Documentation
  • Gap assessments of existing documentation
  • Traceability between requirements, risks, verification and validation
  • Integration of Risk Management into Design Control
  • Stability Studies
  • Transport Tests
  • Review and improvement of Design Control processes
  • Training and knowledge transfer
  • Hands-on Design Control Experience

My experience includes direct preparation of Design Control documentation as well as coordination and review of documentation across R&D, Quality and other relevant functions.

I am used to working within existing development projects and can support both individual documentation activities and broader improvement assignments.

Technical Documentation

I can support the preparation, review and improvement of Technical Documentation for Medical Devices and IVD products, including ensuring consistency and traceability across relevant documentation.

My approach is to understand the product, the development process and the existing documentation before defining what is required to establish an appropriate and compliant documentation structure.

Stability Studies and Transport Testing

I have extensive hands-on experience with stability studies and transport testing, including preparation of protocols and reports.

My experience includes defining study and test requirements, acceptance criteria, coordinating activities, evaluating results and preparing the documentation required to support Design Control and Technical Documentation.

Practical Approach

Design Control should provide structure and objective evidence of a controlled development process without creating unnecessary complexity.

I focus on practical and proportionate solutions that fulfil applicable requirements and can be integrated into the organisation’s existing development and Quality Management processes.

If you would like support with Design Control, Technical Documentation, Stability Studies or Transport Testing, you are welcome to contact me.