Ward Engineering provides a superior product design through our system of documented processes.
Our talented engineers are dedicated to the highest commitment of quality design and critical experimentation. Our quality system is certified to ISO 13485:2003 for contract design, development and manufacture of medical devices and accessories. Our quality system also complies with FDA's 21 CFR Part 820. We have designed our quality system to provide our Clients with well documented, risk assessed medical products and a quick time to market.
Quality activities to help you include:
- Customizing our ISO 13485 quality system to meet your specific company needs and business objectives while meeting applicable regulatory requirements
- Development of procedures and processes to support your project, including utilization of inspection and test equipment such as SmartScope, CMMs, and Instron Tensile/Compression Tester.
- Regulatory submission support, including drafting of submissions
- Oversight and ongoing support of your contract sterilization vendors
- Programs for biocompatibility and sterility testing
- ISO Class 8 clean room and environmental monitoring
- Change control of documents and engineering drawings through our Engineering Change Order process
- Provide completed documentation packages, such as:
- Design History Files
- Device Master Records
- Device History Records (lot files)