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Quality management systems for medical devices production organizations

Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives. (Aldo Leopold)

Medical devices represent a sector whose importance has grown especially considering their impact on health, starting from simpler life support devices, scanning and diagnosis equipment, to the most sophisticated imaging or surgery equipment. Certification of quality management system, particularly for medical devices (ISO 13485) proves to be advantageous, and in many cases essential for medical companies which export their products anywhere in the world.

In the European Union, fulfilling the EU Directives (eg 93/42/EEC, 98/79/EC and 90/385/EEC) allow free trade with medical devices. In a significant proportion, a quality management system according to ISO 13485, demonstrates the compliance with the requirements of EU Directives. The standard is mainly designed for: companies that manufacture medical equipments for medical laboratories who want to enter the EU market on their own; companies that design, manufacture and assemble medical devices and tools for in vitro diagnosis; companies that produce medical components.

ISO 13485

Is a way for creating a management system that aligns with the requirements of regulators;

Is a way of lowering the operating costs - through continual improvement of processes, thus resulting in operational efficiency;

Ensures greater consistency and traceability of products and promotes the necessity of using risk management techniques;

Is a prerequisite for access on high regulated medical devices market.

A certified quality management system according to ISO 13485, demonstrates the organization's commitment and capability to control all aspects of design, manufacture and distribution of medical devices and makes it possible to demonstrate compliance with applicable regulations.

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