1. We conduct an initial consultation with a minimum amount of primary information for the work. Our experts determine the scope of tests.
2. We search for accredited laboratories to perform the necessary tests.
3. We develop a portfolio of necessary documents, such as risk analysis, and clinical evaluation.
4. We create a technical file in accordance with the requirements of the Technical Regulations.
5. Our specialists provide full support of the documentation, including changes and updates. We control all the terms and processes of the proceedings.
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Companies that manufacture medical devices must develop technical documentation for their products to ensure that they meet the requirements of technical regulations. This applies to all risk classes of medical devices, including medical devices for in vitro diagnostics and active implants.
Technical documentation is a necessary component of the product conformity assessment procedure. This technical file provides evidence that the medical device meets the essential requirements outlined in Annex 1 to the Technical Regulations.
Technical documentation is required for medical devices of all risk classes, including Class I, Is, Im, IIa, IIb, and III. It is also necessary for all classes of in vitro diagnostics (IVD A, IVD B, and the group “other”). Furthermore, technical documentation is required for implantable medical devices.
The documentation should include a comprehensive description of the medical device, including any planned modifications and the intended scope of application. It should also include a list of applicable standards, risk management considerations, details of the design, development, production, and quality control processes, as well as test results, design calculations, and inspections.
The technical documentation for a medical device (technical file) contains important documents that determine the compliance of the product with the requirements of technical regulations and ensure its safety and quality. The documentation is drawn up in any form but must contain a sufficient amount of information. The scope of the technical documentation depends on the class of medical device and the chosen method of conformity assessment.
In the case of medical devices, it is also necessary to include the results of preclinical and clinical evaluation. Documentation of medical devices for in-vitro diagnostics should also include an assessment of characteristics such as analytical and diagnostic sensitivity, analytical and diagnostic specificity, accuracy, repeatability, reproducibility, and traceability of nominal values.
