MEDICAL DEVICES

Quality Management

  • Coaching on implementation of a QMS according to ISO 13485 for start-ups
  • Interim Quality Management for start-ups and middle-size companies
  • Support on preparation of ISO 13485 and/or MDR Audits

Development Lifecycle

  • Requirements Engineering
  • Coordination of Verification Activities (e.g.Packaging Validation, EMC Testing,)
  • Moderation of risk management workshops
  • Interim Risk Management (ISO 14971) for start-ups and middle-size companies
  • Reliability Engineering (e.g. MTTF analysis,Moderation of FMEA,…)

Certification and Regulatory Affairs

  • Assessment of medical device classes on target markets
  • Planning regulatory strategy for CE Markt, USA and
    China
  • Support for technical documentation for submissions to notified bodies (STED File, PTR)
  • Review of claims matrices, IFU or marketing brochures
  • Support for renewal of product registrations

 

Post Market Surveillance (PMS)

  • Planning Post-Market Surveillance (PMS) Activities
  • Defining strategies for field data collection (e.g.supported by IT cloud solutions)
  • Review of PMS Reports