Need support with Clinical Evaluation or Clinical Studies?

Our 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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