PE “Consulting service plus” offers services for medical products conformity assessment in the authorized facility.
Conformity assessment of medical devices with the assistance of the authorized body for conformity assessment is required for completing the procedure for:
Conformity assessment with the assistance of the authorized body is:
The result is a certificate of conformity assessment of the medical device (5 years) and a certificate for quality management system (for 3 years).
The result is a certificate for a specific part (supplied) medical devices. In this case, the examination is carried out by the manufacturer provided documentation, a typical example of a medical device for compliance with the technical documentation is verified, the tests are conducted which are needed to determine the appropriate standards, which were chosen by the manufacturer. On-party conformity assessment does not apply to sterile products.
Application, documents and a letter of guarantee are submitted in one of the authorized conformity assessment facilities, which may be different by the composition of experts and inspectors, which can significantly affect the time limits and other aspects of the procedure. Body Selection of conformity assessment is an important and responsible decision that can significantly affect the time limits and cost of certification.
To obtain conformity assessment certificate it is necessary to:
Enterprise quality management system is subject to surveillance audits, which according to the standard DSTU ISO 13485:2005 should be carried out annually. Conformity assessment body needs to carry out periodic checks and evaluations in order to make sure that the manufacturer applies the approved quality management system and also it needs to provide the manufacturer a report on such activities.
The manufacturer should in advance inform the authorized body about any significant planned changes in the production list or its safety, about quality management system changes.
Upon receipt of the Certificate of Conformity, Declaration of Conformity is made up, which is used by customs and accompanies goods in circulation.
We offer a range of services that allows minimizing the financial costs and certification time limits:
High professionalism of our employees and the company's long experience in the field of registration and licensing of medical products enable us to find the optimal solution for the customer in terms of performance and costs, as we have our own accredited centers, laboratories and hospitals.
We look forward to collaborating!