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Why should you choose us?
- We are able to run the complete cycle of tests
- We guarantee dependable results
- We use state of the art test equipment
- We have highly qualified specialists
High Level Professionals
The testing laboratory has a team of experienced specialists who annually undergo internships in international laboratories in the USA and Europe, improving their qualifications and gaining incomparable experience in the field of testing.
We are interested in the development of our employees.
We are interested in the development of our employees.
Zero Doubts
A test report is a document confirming the quality of your products in a competitive market.
The conducted tests will accord you the status of a respected, customer-oriented manufacturer.
The conducted tests will accord you the status of a respected, customer-oriented manufacturer.
Zero Doubts
A test report is a document confirming the quality of your products in a competitive market.
The conducted tests will accord you the status of a respected, customer-oriented manufacturer.
The conducted tests will accord you the status of a respected, customer-oriented manufacturer.
Focus on Development
We do our best to meet the international criteria of IEC, ILAC, APLAC. We develop new lines of business to test EMC, Ex equipment, and mechanical engineering products.
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We do not just conduct tests according to the requirements of Russian and international standards, we set new quality standards in the field of testing laboratory services.
We do everything correctly, efficiently and transparently. We will be glad to see you among
our regular customers!
We do everything correctly, efficiently and transparently. We will be glad to see you among
our regular customers!
The services we provide:
We offer technical tests of medical devices and equipment in order to issue a registration certificate
of Roszdravnadzor
of Roszdravnadzor
The specialists of our organization
will help to quickly prepare
the documents of the quality management system (QMS), implement the QMS
for production and obtain
the ISO 13485 certificate
will help to quickly prepare
the documents of the quality management system (QMS), implement the QMS
for production and obtain
the ISO 13485 certificate
Our experts will offer options
for completing the registration procedure
and help with choosing the optimal
one for a particular manufacturer
for completing the registration procedure
and help with choosing the optimal
one for a particular manufacturer
Technical and EMC tests of medical devices. Our laboratory is accredited by the Federal Service for Accreditation for Testing of medical devices, is placed in the register on the website of Roszdravnadzor. We offer technical tests of medical devices and equipment in order to issue a registration certificate of Roszdravnadzor. The laboratory also has the right to conduct tests for the purpose of registration of the EAEU registration certificate.
If you need a service for conducting technical and EMC tests of medical devices, fill out the form and we will contact you soon!
ISO 13485 certificate. Certification of medical production for
compliance with the GOST R ISO 13485 standard is a voluntary service,
which nevertheless gives significant advantages when passing
the registration procedure of a medical device in Roszdravnadzor. The presence
of the ISO 13485 certificate entitles the manufacturer of a medical device
to obtain a registration certificate without passing
the production inspection procedure.
The specialists of our organization will help to promptly prepare
the documents of the quality management system (QMS), implement the QMS for
production and obtain the ISO 13485 certificate.
Accelerated passage of the procedure is possible if urgent
elimination of the relevant remark of Roszdravnadzor is necessary.
compliance with the GOST R ISO 13485 standard is a voluntary service,
which nevertheless gives significant advantages when passing
the registration procedure of a medical device in Roszdravnadzor. The presence
of the ISO 13485 certificate entitles the manufacturer of a medical device
to obtain a registration certificate without passing
the production inspection procedure.
The specialists of our organization will help to promptly prepare
the documents of the quality management system (QMS), implement the QMS for
production and obtain the ISO 13485 certificate.
Accelerated passage of the procedure is possible if urgent
elimination of the relevant remark of Roszdravnadzor is necessary.
If you need help in obtaining an ISO 13485 certificate, fill out the form and we will contact you soon!
Registration of medical devices in Roszdravnadzor. Specialists of our organization are ready to offer services for the correction and development of technical and operational documentation, organization of all necessary tests, including clinical, as well as interaction with the expertise of Roszdravnadzor within the registration procedure of a medical device. Our experts will help save time and resources, taking into account the accumulated experience, offer options for completing the registration procedure and help with choosing the best one for a particular manufacturer.
If you need help registering medical devices with Roszdravnadzor, fill out the form and we will contact you soon!
