Design-phase testing to achieve your goals quickly and cost-efficiently
The certification of a Medical Device is the ultimate goal of a design and development process that sometimes spans years. For a short time to market and smooth market access accurate planning and determination of the methods that ensure compliance with the Medical Device Directive (MDD) and other applicable directives are of the essence. In support of these goals, TÜV SÜD offers design-phase testing of aspects such as functional safety or assessment of clinical evaluations.
Design-phase testing of functional safety
Design-phase testing offers the possibility to assess functional safety step by step depending on the product′s design stage. It can cover various aspects, including assessment of the functional safety concept, verification of its implementation and review of the technical documentation.
To prevent design errors, the experts can discuss the insulation diagram and special sections of the IEC 60601-1 standard. Technical meetings throughout the product design and development process help to identify possible nonconformities at an early stage in the process. Design-phase testing also includes an assessment of the risk-management file. Also possible are training courses on general subjects such as risk management, MDD and functional as well as electrical safety. The objective is to prevent critical nonconformities at the end of the product-design process.
Pre-assessment of clinical evaluations
Clinical evaluation is the central tool for demonstrating the safety and performance of a Medical Device. Manufacturers frequently commission external laboratories, subcontractors and contract research organizations to plan and realize preclinical and clinical studies. The requirements are complex and there are many strategies for conformity assessment of a product.
Within the scope of our pre-certification service our experts can pre-assess your clinical study protocol, the first version of your clinical evaluation and/or biological assessment, and identify any missing test results at an early stage with regard to the planned certification. This allows manufacturers to assess individual, self-contained modules, such as the validation of sterilisation and packaging, in advance during the preparation of the design dossier and without time pressure. They can then use the result to complete the design dossier and focus their resources in the final phase of the process on the few remaining modules.