Medical Device Consulting
We have around 100 consultants worldwide, some of them in inter-/national committees (ISO, CEN, DIN, AFNOR and UNI), other is scientific working groups.
Our expertise is directly connected to and implemented into our laboratory experience, ensuring an ecosystem of regulatory know-how and practical implementation inside the lab.
Scope of Services
• BEP, BER, BRA per ISO 10993-1:2018
• Test Summary Report/Certificates
• Chemical Characterization Plan
• AET calculation per ISO 10993-18
• Literature Review of the constituents
• Risk Assessment of CMR and ED
• TRA per ISO 10993-17
• Support with NB/FDA non-conformity
• Management of unexpected data
• Validity of studies
• Risk plan review and advice
• Consultancy support
• Gap Analysis
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• Clinical Evaluation Plan
• Literature Review
• Identification & appraisal of data
• Revision of Clinical Evaluation Report
• Filing of Clinical Evaluation Report
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• MDR classification
• Technical File compiling
• 510(k) compiling
• Risk management
• Literature review
• Process line consulting
• Clean room validation
• Sterilization validation
• Disinfection validation
• Reprocessing validation
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• Packaging processes: ISO 11607-2
• Transport simulation: ISO 11607-1
• Shelf-life: ISO 11607-1
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