FRUITION DESIGNS
Fruition offers CE Technical File and Design Dossier compilation and review services.
Fruition specialises in helping medical companies achieve CE marking certification by compiling the relevant technical file for a wide range of Class I, II and III Medical Devices. Here is a checklist of the services we can provide:
Design Input
• Review and compile all the documentation required to meet the Essential Requirements of the Directive
• Assist with the competitor and complaints analysis
• Assist or compile the Clinical Evaluation Report (CER)
Design Synthesis
• Assist and compile the risk management file to ISO 14971
• Compile the risk management plans and reports including FMEAs
• Conduct or manage all the relevant design verification/validation testing required to mitigate any risks or compliance
• Review labelling and IFUs
• Assist with the surgical technique and associated instrumentation
Manufacture
• Process Validations (IQ/OQ/PQ)
• Manufacturing Control Plan
• Identify and assess contact materials
• pFMEA
• Manage or conduct all relevant process testing