Why choose us
How to prepare for a production inspection
Production inspection is a mandatory procedure for manufacturers of medical devices in cases provided for by the current legislation of the Russian Federation. Its purpose is to confirm compliance of the quality management system with legal requirements and assess the ability of the enterprise to ensure stable production of safe and high-quality products.
Successful completion of the inspection directly affects the possibility of state registration of a medical device and its further circulation in the Russian Federation. Insufficient preparation for an inspection can lead to the identification of inconsistencies, an increase in registration time and the need for a repeat inspection.
Our specialists provide comprehensive support for the preparation and passage of a production inspection, helping the manufacturer to successfully complete the inspection and minimize possible risks.
What is included in the service
We provide full support for production inspection, including:
- analysis of the enterprise’s readiness to undergo inspection;
- assessment of the current quality management system;
- checking internal documentation for compliance with established requirements;
- identification of potential inconsistencies and preparation of recommendations for their elimination;
- consulting on preparation for inspection;
- assistance in preparing the necessary documentation and materials;
- support of interaction with the inspecting organization;
- consulting support during the inspection;
- assistance in eliminating comments and preparing corrective actions (if necessary).
Departure of a specialist to the production site
At the customer’s request, we can provide personal inspection support by our specialist directly at the production site.
The expert takes part in preparing the enterprise for inspection, accompanies the manufacturer during the inspection, provides consulting support, helps to quickly resolve emerging issues and interacts with representatives of the inspecting organization.
This service is especially in demand when undergoing the first inspection, as well as for foreign manufacturers. The presence of an experienced specialist allows you to increase the level of preparation of the enterprise, ensure confident completion of the inspection and timely respond to the comments of inspectors.
Result
As a result, you receive professional support for production inspection at all stages - from preliminary preparation to completion of the inspection. An integrated approach allows you to increase the enterprise’s readiness for inspection, reduce the likelihood of identifying inconsistencies and ensure successful completion of the procedure in accordance with the requirements of current legislation.
