Audit of documentation

Purpose of the documentation audit

Verification of documents takes place in several directions:

We eliminate errors in the design. The information should be clear and visual.
We check the uniformity of information. Different documents are compiled at different stages of development, and some information may not match. We check with the client and correct errors.
We make sure that the documentation is complete. Roszdravnadzor gives a month to send additional documents, but not everything can be prepared during this time.
We supplement the information. The dossier should contain enough information about the registered product.
We check each document with the requirements of the department and fill in the gaps.

If inaccuracies in the documentation are not critical, the absence of some documents, for example, on the registration of a trademark, automatically means a refusal of registration. It is difficult to resume the process in this case. Therefore, all documentation must be checked before filing a case with the registration authority. Not only the developer’s documentation is audited, but also conclusions about laboratory tests. There are people working at the test sites, too, and they can also make mistakes.

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The developer of a medical device can develop documentation for it himself: a risk management file, a technical file, a user manual and everything else. But so that Roszdravnadzor does not have any comments, the documents need to be properly executed.

Requirements for registration dossier documents

It is a lot of work to coordinate the documents with the requirements. In 2017, the “Administrative Regulations of the Federal Service for Healthcare Supervision on the provision of state services for the registration of medical devices in accordance with the Rules for Registration and Examination of safety, Quality and Effectiveness of medical devices approved by the decision of the Council of the Eurasian Economic Commission” were adopted, and it specifies 22 regulatory acts. They need to be known when developing or auditing documentation for medical devices. You can re-read all this yourself and rewrite the technical and operational documentation. But this may not be enough. Roszdravnadzor’s comments are not always obvious, and it is possible to understand what can cause them only by experience. Over the years, we have found out this from our own experience, and we know what to pay attention to. Therefore, we do not waste time looking for problems, but solve them.