Medical Devices

The term "medical device" includes all the tools and equipments used alone or with combination of software for use by humans for the purpose of diagnosis, control, prevention, treatment or alleviation of disease. The area is very delicate, because manufacturers have the great responsibility of offering patients maximum benefits, and contain the extreme risks associated with their use.

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Overview

Although at present the demand for innovation means that the time -to-market of products is getting shorter , we must not neglect safety and reliability, especially in this area where the recipients are patients. All medical devices must comply with the national transposition of the " Medical Devices Directive" (Art. 3 Leg. 46/1997 for Italy ) . Quarta EVO , to support the medical device industry in order to produce safe , reliable products and in profitable and timely manner and ensuring that they are competitive and compliant , has targeted some features , such as:

• Complete management of risks;
• Management of Quality Control;
• Efficient management of the Documentation;
• Approach to processes.

The flexible structure of the Quarta EVO allows you to make all business processes compliant with most international standards and regulations. The Quarta EVO platform enables organizations to reduce the costs of compliance , automate processes , manage documents, corrective and preventive actions ( CAPA ) , audits and all other processes of Quality. Quarta EVO is hence preferred software solution which allows Management of Process Quality also in the field of medical devices.

Experiences

The advice and experience in the field of Medical device industry by Blulink can help improve and optimize business processes and allow you to reach an effective adaptation to current regulations, including 21 CFR Part 11, 21 CFR 820, GMP, ISO13485, ISO9000 and other industry standards.