The most challenging aspect of registering medical devices with the manufacturer is the preparation of technical documentation. This applies to both independent applicants and companies working with third pars. The correct preparation of the necessary documents allows for a swift registration process for the manufactured medical devices.
What Technical Types of Documentation are Required for Registration of a Medical Device
- The preparation of source materials is a fundamental step in the creation of a project and the development of the manufactured medical device.
- The development and implementation of a risk analysis strategy. All initial data has been taken into account. It is not possible to obtain a registration certificate from Roszdravnadzor without first carrying out a risk assessment of the equipment in question.
- Design documents. The complex includes the following: drawings, technical conditions, operational characteristics, warranty cards and service features.
- All devices are tested. Medical devices shall be registered with the correct protocols for the studies that have been conducted. These decisions determine whether a registration certificate for a medical device will be granted.
- Verification of all input data and materials gathered at the conclusion of the process, following the completion of a various comprehensive measures.
- Technological types of documents. These include descriptions of the deviceion process, validation protocols, instructions and recommendations, and an inventory of the process of providing services for the installation, maintenance and repair of medical equipment.
- Preparation of an application to be submitted to Roszdravnadzor.
Thus, technical documentation shall be prepared based on legislative norms. If you need quality assistance in preparing technical documentation for a medical device, feel free to contact us! Professional and experienced employees of our MedReg Consulting company will be able to quickly prepare the necessary documents, obtain protocols and reports with conclusions. The papers are drawn up using the recommendations of government agencies.