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Registration Service RF · EAEU Government Decree No. 1416

Development and execution of documentation

Specifications, manuals, risk management file, medical software validation.

01 / Description

Specifications, manuals, risk management file, medical software validation.

02 / Scope of work

What the service includes

  • 01 Development of technical specifications (TS) or regulatory document
  • 02 Drawing up an operating manual/instructions for use
  • 03 Development of a risk management file (RMF) and clinical assessment report
  • 04 Preparation of marking layouts and photographic images
  • 05 Development of serviceability documentation
  • 06 Medical software validation
  • 07 Validation of sterilization and packaging processes
Cross-references

These services are frequently ordered together with the current one for comprehensive registration support.

УСЛУГА 01 ON REQUEST

Consulting and preliminary examination

Initial audit of documentation, determination of risk class and medical device type code, selection of registration strategy.

RF · EAEU
jurisdiction
open
УСЛУГА 02 ON REQUEST

Organization and support of tests

Selection of laboratories, technical, toxicological, clinical tests.

RF · EAEU
jurisdiction
open
УСЛУГА 03 ON REQUEST

Preparation for production inspection, QMS, certification

Implementation of QMS from scratch, production audit, ISO 13485, CE marking.

RF · EAEU
jurisdiction
open
Inquiry form · 24 hours

Enquiry for «Development and execution of documentation»

Specify the device type and current registration stage — we will prepare a cost and timeline estimate under Government Decree No. 1416 within 24 hours.

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