1. Consulting on the selection and implementation of the QMS, based on the manufacturer’s capabilities.
2. Conducting a diagnostic audit to assess the readiness of production for the implementation of the QMS. We analyze the infrastructure, resources, equipment, production environment, and employee qualifications.
3. Development of QMS documentation per the requirements of ISO 13485, including quality management procedures, work instructions, and record forms.
4. Training the company’s employees in maintaining quality management system documentation. We provide training in record keeping, internal audits, complaint response, production route maps, and collecting post-production/post-sales information, etc.
5. Supporting the client at all stages of work with the QMS documentation, including eliminating inconsistencies identified during QMS audits, making appropriate changes, and clarifying all issues that may arise during work with the QMS documentation. We are ready to help our clients even after obtaining all approvals and certificates.
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ISO 13485 is an international quality management standard that was developed specifically for medical device manufacturers. It defines the requirements for a quality management system, given that an organization can prove its ability to systematically provide medical devices and related services that meet the requirements of the customer and regulatory authorities.
The requirements of this standard apply to organizations, regardless of their size and type, unless explicitly stated otherwise.
The production and distribution of medical devices is an industry with high quality and safety requirements. Therefore, companies involved in this business must establish a quality management system (QMS). For medical devices, ISO 13485 is a quality management standard that sets out the requirements for a QMS.
Certification of the management system is mandatory for the production of medical devices and medical devices for in-vitro diagnostics. In other cases, such certification is voluntary. DSTU EN ISO 13485:2018 is the quality management standard for medical devices in Ukraine, which corresponds to the international standard ISO 13485:2016 and is included in the list of European harmonized standards. Its application is a presumption of compliance with the Basic Requirements of the Technical Regulations.
