PRoduct Design
& Development

Medical Devices

 

  • Support with preparation of design & development documents

Everything starts with setting up a sound design & development plan to coordinate all design & development activities and responsibilities. Afterwards, the design requirements will be determined and will form the basis of the verification activities. Based on the design requirements, we will support to derive the design specifications according to the design requirements. Once completed, the appropriate design verification and validation activities will be determined. Our design experts will guide you through the complex design process and understand all relevant interfaces like risk management, usability engineering, biological and clinical safety.

  • Support with preparation of risk management documents

Our experts will create the appropriate risk management documentation to comply with the relevant regulatory requirements (planning, analysis, reporting), always bearing in mind the balance between meeting high quality standards and the economic situation of our clients.

  • Support with preparation of usability engineering documents

Our experts will create the appropriate usability engineering documents to comply with relevant regulatory requirements.

  • Organisation of verification and validation activities

The necessary verification and validation activities (e.g. test laboratories) are often complex and need specialized partners to meet the appropriate standards of the regulatory requirements. We will identify the suitable partners, who will fulfill the standards and delivers the best economic solution for you.

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