First Complex Registration Company
34 1st Kuryanovskaya street, building 11, Moscow
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Quality Management System in a Medical Organization

Quality Management System in a Medical Organization
Quality Management System in a Medical Organization
Стоимость рассчитывается индивидуально

As we know, Roszdravnadzor is a supervisory body. It controls the circulation of medical devices and medicines, quality and safety of medical activities, etc.

Respectively, any medical device has a good chance to be inspected by Roszdravnadzor, where any registration data inconsistency may be detected.

As a result, a medical device may be withdrawn from circulation in some cases, which potentially results in large losses even for a relatively small enterprise. And if we talk about a large-scale producer participating in public procurement, such product withdrawal may be really disastrous.

Our specialists have extensive experience in resolving issues related to:

- Suspension of the use of medical devices - Withdrawal of medical devices from circulation — Recognition of medical devices as unregistered, substandard or falsified.

What Shall We Do for You?

We offer services of support during the inspection and solution of issues thereafter. We help a manufacturer mitigate any risk as much as possible and, if a crisis occurs after the inspection, address it as smoothly as possible.

Our services:

- Consultation on the resulting control and supervisory activities;

- Introduction of amendments into the manufacturer’s documentation;

- Preparation of letters and requests to Roszdravnadzor;

- Interaction with law enforcement agencies;

- In case of initiation of a criminal case, provision of a qualified lawyer.

We do everything to ensure that your loss of money and time is minimal.

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