Do you need help with the following, then please contact me:

• Consultant within medical device and In Vitro Dianostic industries
• Regulatory advice (including MDR and IVDR)
• EU and US certifications
• Create documentation
• Conduct and document verifications and against requirements e.g. Bio evulation, packaging and technical requirements
• Set the right requirements for products
• Clinical evaluation reports
• Project management
• Review and submitting documentation package to the authorities

Experience with the following companies:

- Radiometer, link

- Timedico, link

- Medotech - Start up company

Non Medico:

- Siemens Wind Power, link (Certifications)