Plextek's Quality System for Medical Devices

Medical product development relies on the designer's quality system to ensure that both the product and the design documentation are to the required standards of the relevant notified bodies.

Plextek's proven track record with the development of both medical and biomedical projects allows you the confidence to approach us and discuss your needs:

• Full design capabilities and experience of design for medical safety IEC 60601-1, laboratory equipment safety IEC 61010-1, and IVD safety IEC 61010-2-101
• EMC for medical devices IEC 60601-1-2 and laboratory equipment IEC 61326
• Medical devices risk analysis to ISO 14971
• Specific procedures in our ISO9001 quality system to support medical quality management ISO 13485
• Documentation for application to European Notified Bodies under EC Directives for Medical Devices 93/42/EEC and In-Vitro Diagnostic Medical Devices 98/79/EC
• Documentation for United States Federal Drugs Administration for applications under FDA 510(k)

Company Quality System

Plextek operates a comprehensive and flexible quality system which can be tailored to suit the size and complexity of the project in development.

Each project is assigned both a Project Manager, responsible for day-to-day running of the project, and a Project Assessor, who acts as an independent quality auditor and advisor. All Plextek projects are operated in accordance with defined quality procedures and are regularly reviewed both internally and with the client. Our clients are continually involved in all decisions relating to the project and receives regular progress reports.

Auditing and Approvals

Plextek holds BS EN ISO9001:2000 certification.

For more information, please contact us.