Clinical Affairs

Clinical Evaluation, Full-Service CRO, and Post-Market Clinical Follow-up for Medical Devices


Need support with Clinical Evaluation or Clinical Studies?

Clinical Evaluation is the final validation of a medical device to confirm that the device performs as intended and can safely be used in patients in accordance with its instructions for use. Worldwide regulatory requirements prescribe how such Clinical Evaluation needs to be completed. Specific regulatory requirements regarding Clinical Evaluation exist for example, in the US, EU, and China. Key principles of Clinical Evaluation are the same in the different regulatory regions.








All our Clinical services

Clinical Consultancy

  • Clinical development plan
  • Sufficient Clinical Evidence
  • MDR readiness and implementation
  • Clinical Evaluation Plan (CEP)
  • Literature review
  • Clinical Evaluation Report (CER)
  • MEDDEV 2.7/1 rev 4 compliance
  • Clinical problem solving
  • Training
  • Clinical Audit
  • Worldwide support

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Interim Clinical Support

  • Temporary support
  • Replacement
  • On-site or remote
  • Clinical department development
  • Coaching and training
  • Clinical Study Management
  • Site Monitoring
  • Alignment with QA/RA and marketing roles

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CRO services

  • ISO 14155/ GCP compliance
  • Pre-CE study design and management
  • PMCF study design and management
  • Define Study Endpoints
  • Protocol/ CIP development
  • Investigator Brochure
  • Case Report Form (CRF)
  • Informed Consent (ICF)
  • CA/ EC  submission
  • Site selection, training, and management
  • Monitoring
  • Statistics
  • Data management
  • EDC selection
  • Audits
  • Remediation of non- compliant studies

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"I strongly believe in the value of a practical and user-friendly approach while ensuring a high standard of quality. I look forward to helping customers bring their products to the market efficiently in an increasingly demanding regulatory environment. Does your medical device lack clinical data? We can help determine how to efficiently close those gaps and support your clinical investigations."

- Wiebe Postma, Clinical Investigation Expert


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