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
Ely, Cambridgeshire, United Kingdom, Europe
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
Contract manufacturing (turnkey)
Concept-to-market contract manufacturing and assembly of medical devices, including implants, drug-delivery devices, consumables and associated tooling/engineering support.
Contract packaging
Cleanroom and non-cleanroom packaging services including pouch and blister loading/sealing, procedure pack assembly, label application and seal integrity testing.
Quality assurance and regulatory support
Quality system administration, validation support (IQ/OQ/PQ), CAPA/change control, supplier audits and assistance with CE marking and FDA listings.
Label design and printing service
In-house label design, printing, origination and barcode implementation, with support for UDI compliance and outsourced large-volume label procurement management.
Sterilisation management
Management and coordination of external sterilisation services including irradiation and ethylene oxide processing as part of the product release pathway.
Contract manufacturing (turnkey)
Concept-to-market contract manufacturing and assembly of medical devices, including implants, drug-delivery devices, consumables and associated tooling/engineering support.
Contract packaging
Cleanroom and non-cleanroom packaging services including pouch and blister loading/sealing, procedure pack assembly, label application and seal integrity testing.
Quality assurance and regulatory support
Quality system administration, validation support (IQ/OQ/PQ), CAPA/change control, supplier audits and assistance with CE marking and FDA listings.
Label design and printing service
In-house label design, printing, origination and barcode implementation, with support for UDI compliance and outsourced large-volume label procurement management.
Sterilisation 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)