A successful certification does not only consist of a suitable quality management system but also requires an appropriate documentation. We support you with analysing the actual requirements and with creating a documentation that fulfills all demands of the respective certification.
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.
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.
Our experts will create the appropriate usability engineering documents to comply with relevant regulatory requirements.
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.
Specific topics include:
Evaluation of the sterile aspects (e.g. sterile-validation), packaging and transport-validation of medical devices.
Our experts and specialists worldwide can help with your individual queries related to medical devices. Get in touch!