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ISO 13485
WHAT IS ISO 13485?
ISO 13485 is an international industry-specific standard that contains requirements for the quality management system of companies involved in the production of medical devices.
When this standard applies
This standard is applicable if you have the following objectives:
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When creating and implementing a management system within a company engaged in the production of medical devices.
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When the company desires to demonstrate its ability to manufacture medical products (provide services) of predictable quality that meet relevant requirements and/or customer expectations.
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For conducting European certification of products (CE marking), which is essential for selling and using medical devices within the European Union.
This standard is based on ISO 9001 with consideration for the specific requirements of the medical industry. Therefore, companies that already have a quality management system compliant with ISO 9001 should not find it particularly challenging to "upgrade" to ISO 13485.
Please note that in Ukraine, for companies engaged in the mass production of medical products, having an ISO 13485 certificate is mandatory, as this certificate is required for the technical file.
Advantages of ISO 13485 Certification:
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Passing the conformity assessment procedure for medical devices.
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Improved product quality and reduced risk probability.
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Increased employee responsibility.Optimization of material and technical resource usage, streamlining administrative and production processes.
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The opportunity to enter the international market due to global recognition of the standard.
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Increased business investment attractiveness.
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Competitive advantages when participating in tenders, competitions, and auctions.
what else do we offer?
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Development of document sets, methodologies, regulations, etc.
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Consultations on implementation, both one-time and ongoing
Organization and conduct of training for internal auditors.
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Development and implementation of systems within the company.
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Organization and execution of certification.
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Organization and execution of testing for your products in European laboratories and obtaining the EU Certificate.
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