Effective and efficient solutions for your medical device

Quality Management

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From Audit preparation to establishing a completely new QMS

  • Slim QMS for small companies and start-ups
  • QMS (e.g. ISO 9001, ISO 13485, QSR, MDSAP)
  • Internal Auditing and Gap Analysis
  • Audit Remediation Projects

Product Development/Technical Documentation

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Documentation from the first idea to registration and successful market launch

  • Validation of product and processes
  • Traceability management of specifications
  • Software and Hardware 

Risk Management

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  • Introduction of an ISO 14971-compliant Risk Management process
  • Creation of risk analyses and FMEAs
  • Support in creating a Risk Management File 


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  • Support of CE – marking process
  • Clarification of international approval requirements
  • Support in drafting of registration dossiers (e.g. FDA 510(k))

Trainings & Workshops

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  • Training of QMS documents
  • GDocP – Training
  • Risk Management workshops