'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.

To download a copy of this certificate, please click directly on it.

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:

Lloyd Instruments LF Plus Single Column Material Tensile Strength Tester

Baty Venture 2510 3D Benchtop Contactless CMM Machine

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