Biophoenix Ltd
Medical Equipment Manufacturing
We assist clients with implementation of EU MDR and IVDR compliant processes.
About us
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.
- Industry
- Medical Equipment Manufacturing
- Company size
- 2-10 employees
- Headquarters
- Kenilworth
- Type
- Privately Held
- Specialties
- Medical Devices, MDR Compliance, MEDDEV 2.7/1 Rev 4, and Clinical Evaluation
Locations
-
Primary
Get directions
40 Station Road
Kenilworth, CV8 1JD, GB