Initial situation
A manufacturer from China was introducing a digital X-ray machine with its own image processing software to the Russian market. The main difficulties: the software part required validation as medical software, electromagnetic compatibility was not confirmed using Russian methods, operational documentation was only in English.
What we did
- Translation and adaptation of operational documentation (350+ pages)
- Software validation according to GOST R IEC 62304 with preparation of a complete package of evidence
- Organization of EMC tests in an accredited laboratory, coordination with the manufacturer
- Development of a risk management file according to ISO 14971
- Submission to Roszdravnadzor, support of technical and clinical examination
Issued Registration Certificate
The registration certificate was received in 6 months - 30% faster than the market average. The device was certified and was included in the supply catalog for government procurement. The first deliveries to regional clinics began 2 months after registration.