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Registration Service RF · EAEU Government Decree No. 1416

Preparation for production inspection, QMS, certification

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

01 / Description

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

02 / Scope of work

What the service includes

  • 01 Consulting on preparation for inspection
  • 02 Analysis and development of QMS documents
  • 03 Preliminary production audit
  • 04 Inspection support
  • 05 ISO 13485 Certification
  • 06 Consulting on CE marking
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

Development and execution of documentation

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

RF · EAEU
jurisdiction
open
УСЛУГА 03 ON REQUEST

Organization and support of tests

Selection of laboratories, technical, toxicological, clinical tests.

RF · EAEU
jurisdiction
open
Inquiry form · 24 hours

Enquiry for «Preparation for production inspection, QMS, certification»

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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