We can support you in handling challenges and questions arising throughout your medical device’s life cycle and help your company navigate regulatory requirements for obtaining a CE mark. We have extensive experience within medical devices and IVD products and can help you identify the appropriate structures and applications. 

• • All phases of CE certification and CE marking of all classes of medical and IVD devices
• • Support with biological and clinical evaluation 
• • Support with external test set-ups
• • Audits
• ⁃ Internal audits
• ⁃ Third party audits (supplier audit)
• ⁃ Preparation and support for FDA inspections
• ⁃ Product audits: audit of technical files and fulfillment of MDR
• • Integrating risk management according to latest ISO 14971 in your quality system
• • Set-up of the Post-market surveillance process
• • Training and introduction to different risk analysis methods

Medical writing 

• • Clinical investigation documentation according to ISO 14155, MDD 93/42/EEC, MDR 2017/745
• • EC/IEC/IRB and CA/RA submissionsClinical investigation plan (CIP)
• • Case report form (CRF), Investigator’s brochure (IB), Patient information (PI) and Informed consent form (ICF) Clinical evaluations report (CER)
• • Site visits, project management and monitoring
• • Standard operating procedures, templates and forms