'Quality is everyone's responsibility' - We have a fully trained, in-house Quality Assurance Team to ensure our customers quality expectations are fulfilled.
- Quality Systems approval (various) for over 70 years.
- ISO 13485 (2016) approved since inception of the standard (one of the first 1% of UK Medical Device Businesses to be approved), notified body BSI.
- Manufacturer of FDA approved devices (in excess of 60 devices). FDA registered Contractor with Device Listings.
- FDA registered site (#8044131)
- Certified ISO 14644-1 Class 7 Cleanrooms (2 Rooms)
- Quality department of 5 members of staff.
- Audited and approved by Japan Focus for export to Japan 2009 & 2011.
- Audited by multiple major Notified Bodies in conjunction with CE marking of our Clients products.
Our Experienced team provide the following quality assurance activities:
- Mature Client Files, Archiving, Supplier Approval (Including supplier audits), Calibration and Internal Auditing Systems.
- CAPA & Change note systems with turnaround measures.
- A fully audited Training Matrix system.
- The trending of test results.
- SPC capabilities.
- Validation support.
- Installation, Operation and Performance Qualifications (IQs/OQs & PQs).
- Risk Assessment and Management .
- Document Origination - Standard Operating Procedures, Works Instructions, Controlled Forms/Templates and Batch History Records.
© Wesley Coe (Cambridge) Ltd, Gas lane, Ely, Cambs, CB7 4GH, UK.
Company Registration Number - 00502988