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:
Quality Management System
- ISO 13485
- ISO 9001
- 21 CFR 820
- CMDCAS
- Auditing
- Gap Analysis
Auditing
- Internal audits
- Supplier audits
- Mock regulatory inspections
Process Validation
- IQ
- OQ
- PQ
Interim Support
- Interim Quality Manager
- Interim QA support
- Special projects
- Temporary contracts
- Part time contracts
- On going support
Dot Medical used High Edge Consulting to provide advice and assistance with moving from ISO9001:2000 to ISO13485:2003 as well as obtaining CE mark for a Class III medical device. They provided first class consultancy over a period of 6 months in 2008/2009 after which our CE mark and ISO certifications were approved at the initial audit. In addition, their consultants microbiology background proved invaluable to help us resolve issues around validation of sterilisation and testing procedures.
Since achieving certification and CE mark, we have retained High Edge Consulting’s services on a monthly basis to provide internal audit and on-going advice regarding regulatory issues which arise from time to time. We are delighted to be able to work with them in this way and value their skills and knowledge, they are always prepared to ‘go the extra mile’ to assist. High Edge Consulting has always provided the service promised and usually a bit more too.
Janet Bishop, Director of Operations, Dot Medical Ltd
