OxDevice are dedicated to maintaining the highest standards, and we operate at the topmost level of business ethics and compliance. With ISO 13485 certification we are fully committed to best practice in medical design and development.
Many of our customers are start-ups or are new to medical devices with little experience of the complex regulations which apply. Our many years of real-world experience enable us to provide quality and regulatory support in all areas including the following:
- Design & development planning
- Understanding and documenting intended use, user needs and design inputs
- Planning, hosting and documenting design reviews
- Documenting of component specifications
- Selecting, approving, and managing suppliers
- Goods Receiving, inspection and storage of materials and components
- Leadership of your risk management process from initial planning and hazard analysis through to detailed FMEAs
- Management of your testing programmes as part of the design & development process, including pre-clinical studies and bench testing
