Wesley Coe (Cambridge) Ltd - Medical Device Manufacturer UK
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Quality Assurance

Call Us Now on +44 (0)1353 667914
'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.
ISO 13485:2016 at Wesley Coe (Cambridge) Ltd, Ely, Cambridge UK
To download a copy of this certificate, please click directly on it.
Quality assurance at Wesley Coe (Cambridge) Ltd, medical device manufacturing and packaging specialists based in Ely UK.
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.
We have an extensive range of inspection equipment, including:
Peel testing at Wesley Coe (Cambridge) Ltd, medical device manufacturer UK
Lloyd Instruments LF Plus Single Column Material Tensile Strength Tester
CMM scanning at Wesley Coe (Cambridge) Ltd, medical device manufacturer UK
Baty Venture 2510 3D Benchtop Contactless CMM Machine
shadow graphing at Wesley Coe (Cambridge) Ltd, medical device manufacturer UK
Baty R14 Vertical Shadow Graph Profile Projector

For More Information...

Please contact Colin Jones on sales@wesleycoe.com or call us on +44 (0)1353 667914
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Telephone: +44 (0)1353 667914
Email: sales@wesleycoe.com
Business Hours:
​Monday - Thursday
7.30AM to 4.30PM
Friday
7.30AM to 12.30PM
ISO 13485:2016 accreditation at Wesley Coe (Cambridge) Ltd, medical device manufacturer UK
Wesley Coe (Cambridge) Ltd, medical device manufacturer based at Ely, Cambridge UK are FDA Registered.

© Wesley Coe (Cambridge) Ltd, Gas lane, Ely, Cambs, CB7 4GH, UK.
Company Registration Number - 00502988