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