Providing Regulatory and Quality compliance solutions to the medical device industry
High Edge Consulting can provide you with assistance and consultancy in the following areas:
Medical device auditing services
- Internal audits
- Supplier audits
- Mock regulatory inspections
- Gap analysis
Auditing Regulatory and Quality Compliance
- 93/42/EEC Medical Device Directive
- 98/79/EC In Vitro Diagnostic Medical Devices Directive
- 90/385/EEC Active Implantable Medical Devices Directive.
- ISO 13485
- ISO 9001
- 21 CFR 820
- CMDCAS
- Microbiology
- Cleanroom
BPR Medical are the fastest growing independent manufacturer of oxygen therapy and medical gas control products. We are proud of our reputation as a company that offers competent design and a friendly service. We engaged High Edge to carry out internal audits to support our regulatory and quality systems. It was a pleasure to find that their culture is identical to ours. They are very competent and very friendly.
Richard Radford - Managing Director, BPR Medical
PS - At the recent Medilink East Midlands Award Ceremony, BPR Medical won the prestigious Healthcare and Bioscience Innovation Award for its FireSafe™ product group.