Wesley Coe
Wesley Coe (Cambridge) Ltd is a medical device manufacturer and packaging specialist based in Ely, Cambridgeshire, UK. With over 70 years of experience, they specialize in contract manufacturing, assembly, and packaging of medical devices, serving clients across the UK, Germany, Sweden, France, and Ireland. Their mission is to provide reliable, flexible, and professional services using the latest technology, ensuring customer satisfaction. They are committed to quality, holding ISO 13485:2016 accreditation, FDA registration, and operating in controlled environments with comprehensive quality assurance and testing capabilities.
Industries
Nr. of Employees
medium (51-250)
Wesley Coe
Products
Procedure packs
Ergonomically arranged kits containing all items required to carry out a routine clinical procedure, assembled and packaged for single-use clinical deployment.
Implant assembly and packaging
Cleaning, wiring, assembly and packaging services for implantable devices including middle ear implants, dental implant systems and other implantable product lines.
Device consumables and applicators
Manufacture and packaging of consumable device components and application devices such as biopsy markers, analyser consumables and device applicators.
Procedure packs
Ergonomically arranged kits containing all items required to carry out a routine clinical procedure, assembled and packaged for single-use clinical deployment.
Implant assembly and packaging
Cleaning, wiring, assembly and packaging services for implantable devices including middle ear implants, dental implant systems and other implantable product lines.
Device consumables and applicators
Manufacture and packaging of consumable device components and application devices such as biopsy markers, analyser consumables and device applicators.
Services
Concept-to-market contract manufacturing and assembly of medical devices, including implants, drug-delivery devices, consumables and associated tooling/engineering support.
Cleanroom and non-cleanroom packaging services including pouch and blister loading/sealing, procedure pack assembly, label application and seal integrity testing.
Quality system administration, validation support (IQ/OQ/PQ), CAPA/change control, supplier audits and assistance with CE marking and FDA listings.
In-house label design, printing, origination and barcode implementation, with support for UDI compliance and outsourced large-volume label procurement management.
Management and coordination of external sterilisation services including irradiation and ethylene oxide processing as part of the product release pathway.
Concept-to-market contract manufacturing and assembly of medical devices, including implants, drug-delivery devices, consumables and associated tooling/engineering support.
Cleanroom and non-cleanroom packaging services including pouch and blister loading/sealing, procedure pack assembly, label application and seal integrity testing.
Quality system administration, validation support (IQ/OQ/PQ), CAPA/change control, supplier audits and assistance with CE marking and FDA listings.
In-house label design, printing, origination and barcode implementation, with support for UDI compliance and outsourced large-volume label procurement management.
Management and coordination of external sterilisation services including irradiation and ethylene oxide processing as part of the product release pathway.
Expertise Areas
- Medical device contract manufacturing
- Contract packaging and sterile barrier systems
- Cleanroom manufacturing and environmental monitoring
- Quality management and regulatory compliance (ISO 13485, FDA listings)
Key Technologies
- ISO 14644-1 Class 7 cleanroom manufacturing
- Pouch and blister sealing systems
- Label printing and barcoding
- Management of sterilisation pathways (irradiation, ethylene oxide)
News & Updates
ISO 13485:2016 Certification Achieved
Wesley Coe became one of the first UK contract medical manufacturers to achieve ISO 13485:2016 certification with BSI.
FDA Registration
The company is FDA registered, with site number 8044131, supporting their compliance and manufacturing of FDA-approved devices.
Wesley Coe's Commitment to Quality
The company emphasizes quality as everyone's responsibility, with a fully trained in-house Quality Assurance team and compliance with multiple international standards.
Industry Recognition
Industry experts recognize Wesley Coe for their quality-first approach and customer-centric services.
ISO 13485:2016 Certification
Achieved ISO 13485:2016 certification, demonstrating compliance with international standards for medical device quality management.
FDA Registration
Registered with the FDA, supporting their capability to manufacture and supply FDA-approved medical devices.
ISO 13485:2016 Certification Achieved
Wesley Coe became one of the first UK contract medical manufacturers to achieve ISO 13485:2016 certification with BSI.
FDA Registration
The company is FDA registered, with site number 8044131, supporting their compliance and manufacturing of FDA-approved devices.
Wesley Coe's Commitment to Quality
The company emphasizes quality as everyone's responsibility, with a fully trained in-house Quality Assurance team and compliance with multiple international standards.
Industry Recognition
Industry experts recognize Wesley Coe for their quality-first approach and customer-centric services.
ISO 13485:2016 Certification
Achieved ISO 13485:2016 certification, demonstrating compliance with international standards for medical device quality management.
FDA Registration
Registered with the FDA, supporting their capability to manufacture and supply FDA-approved medical devices.