Conformity assessment through procedure для for medical devices
An important step to confirm the compliance of medical devices with the requirements of Ukrainian legislation. Confirm the compliance of your products with the requirements of Ukrainian legislation with expert support at every stage
What does conformity assessment involve?
This procedure involves the assessment of the manufacturer's quality management system and ensures compliance with all required standards.
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Important to know
Starting from 2021, most audits are conducted online, which significantly reduces time and costs for both manufacturers and auditors. This approach allows for a faster and more efficient assessment of compliance, although on-site audits are still required for certain products.
Medical Hub provides comprehensive support at every stage
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Development, adaptation and verification of technical documentation
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Legal and organizational support
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Assistance in the selection of a conformity assessment body depending on the choice and other aspects
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Support until the certificate is obtained
Stages of the audit procedure
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Preparation of technical documentation
The manufacturer submits to the conformity assessment body the technical documentation for the products, as well as documents on the quality management system. It is important to ensure that the documentation meets the requirements of the authority, in particular with regard to translations and legalization.
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Conducting an audit
After submitting the documentation, the authority initiates an audit. Online audits are conducted according to pre-agreed schedules with a detailed audit plan. If necessary, on-site audits are organized.
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Resolving comments
If comments arise during the audit, the manufacturer is given time to eliminate them and submit additional documentation
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Issuance of the certificate
After successful completion of the audit, a certificate of conformity assessment is issued, valid for 5 years. Based on this certificate, the manufacturer or his authorized representative has the right to issue a declaration of conformity
Regular surveillance audits to maintain compliance
After the certificate is issued, surveillance audits are conducted annually, mostly online, with the possibility of making changes to the valid certificate, such as changing the name of products, expanding or reducing the list of products, changing the address or name of the manufacturer