ISO 13485

Quality Management of Medical Devices

What is ISO 13485 standard?

EU directives and Greek legislation specify the development of a quality management system for medical devices applicable to producers, importers, traders and distributors. System implementation covers company’s compliance obligations regarding EOF (National Organization for Medicines) requirements, MDR regulation, Ministerial Decision (YA) 1348/2004 etc.

Through implementing the system, the company can obtain the international ISO 13485 certificate or the YA 1348 certificate of implementation by an independent accredited body. The certification, besides adding value to an organisation and enhancing the marketing, creates new business opportunities in the medical device market.

ISO 13485 benefits

Compliance with the legislation requirements (harmonization with EU Regulation 2017/745 (MDR), 2017/746 (IVDR) and National (Hellenic) Ministerial Decision (YA) 1348/2004 etc.)
Strengthening the company’s relations with its stakeholders (staff, customers, suppliers, etc.)
Enhanced planning and improved customer satisfaction
More efficient handling of product recall cases and failures
Enhanced staff training and adoption of a quality culture in business operations’ management
Enhanced business reputation and building trust with customers
Competitive advantage
Access to public tenders, including EU and non-EU markets
Easy extension to other MDSAP, CMDCAS standards for exporting to countries implementing them

Role of IDEC S.A.

Infrastructure requirements’ assessment and determination, if applicable, in accordance with standard and legislation.
Risks’ and opportunities’ assessment
Development of required documentation (Manual, procedures, documents)
Scientific support for checking the conformity of technical files, technical brochures, declarations of conformity, medical devices’ instructions and markings, in accordance with the applicable legislation and other requirements
Training in management system’s and legislative requirements’ implementation
Consulting services for the certification planning and preparation according to ISO13485 international standard & ISO13485 and the National (Hellenic) Ministerial decision (YA) 1348/2004
Management system monitoring and support according to the current needs following the initial certification
Scientific support and information on relevant legislation and regulations