Ward Engineering has the expertise and facilities to bring your concept through to short run or clinical manufacturing.
Under stringent quality controls, we manufacture precision components and accurately assemble and package products. Our ISO Class 8 clean room which meets the ISO 14644-1 standard is ideal for assembling medical devices that require a low bioburden environment.
Process development and validation
- Compile Device Master Record
- Manufacturing and assembly tooling and/or fixtures
- Process FMEA
- Protocols, quality assurance testing and reporting
- Equipment qualifications (IQ, OQ, PPQ)
Packaging development and validation
- Specifications, design, and development
- Clean room tray and pouch sealing
- Complete integrity testing
- Perform sterilization validation
Material Controls
- Vendor controls
- Incoming materials inspection
- Device History Record maintenance
- Device specifications and BOMs
- Fabrication and assembly instructions
- Lot control and traceability
Precision fabrication
- ISO 9001:2000 certified machine shop via Selecteon® Corp (www.selecteon.com)
Expert assembly
- 20+ years experience in electromechanical and medical device assembly
- Class 100,000 clean room
