TESTING AND REGISTRATION OF MEDICAL DEVICES
Оставьте свой номер телефона и мы c Вам перезвоним
What is registration and why is it necessary to obtain a registration
certificate for medical devices?
certificate for medical devices?
A registration certificate is a permit document that gives the right to sell and use any medical devices (including equipment, consumables, drugs, tablets) on the territory of the Russian Federation.
The requirements for testing laboratories that have the right to conduct technical tests of medical devices for the purpose of their registration are regulated in the Rules for Conducting Technical Tests of Medical Devices approved by the Decision of the Council of the Eurasian Economic Commission No. 28 dated 12.02.2016. The ULC Quality testing laboratory on the Roszdravnadzor website is included in the list of testing laboratories authorized to conduct technical tests of medical devices for registration purposes.
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!
Why do customers choose us?
Quality assurance
of testing
of testing
Strict compliance
with the agreed
deadlines
with the agreed
deadlines
High-tech
equipment
equipment
Official
test reports
test reports
Thank you letters
We have been working in the field of medical testing and registration for more than 10 years. Our clients value efficiency, competence and the opportunity to get professional help even in non-standard situations. Our engineers regularly undergo professional training, including in laboratories in Europe and China. We regularly go to the production of medical devices to our customers. We value the loyalty of our customers and constantly justify their trust and loyalty. We will be glad to cooperate.
We regularly expand the scope of laboratory accreditation in order to offer
the client a full range of technical tests and EMS for medical
devices of all risk classes.
the client a full range of technical tests and EMS for medical
devices of all risk classes.
