Biophoenix Ltd
medical devices
About
Biophoenix assists clients with implementation of MDR and IVDR-compliant processes. Services include: preparation of CEPs, CERs, SSCPs, PSURs, PMCF Plans/Reports for medical devices; PEPs and PERs for IVDs; assembly and evaluation of product technical documentation. The principal medical writer, Dr Beata Wilkinson, has 20+ years industry experience and has prepared in excess of 60 CERs as well as other documents required for CE marking of medical devices. High quality, price-competitive service. Professional liability insurance.
Keywords
meddev 271 rev 4
clinical evaluation
medical devices
mdr compliance
medical equipment manufacturing
hospital & health care
Company Information
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Employees 2
Location
Kenilworth, England, United Kingdom, CV8
