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REST ASSURED! Medical and Healthcare™

Does your device meet the FDA and European Commission requirements?

The Healthcare and Medical sector is a complex and widely dispersed domain. It is comprised of pharmaceutical manufacturers, biotechnology companies, medical device suppliers, government authorities (such the U.S. Food and Drug Administration (FDA) and the European Commission), healthcare providers, insurers, and consumers. This sector is a dynamic entity, rapidly moving towards highly automated and electronic environments in which the storage, management, and use of complex information is essential for success. However, such automated and computerized systems have – especially due to their software components – substantial risk potential for patient safety. This is especially pertinent due to the fact that they many of these system have direct or indirect impact on the quality of the drugs manufactured for use by human beings as well as animals.
Focusing on the unique requirements of the Medical and Healthcare industry, REST ASSURED Medical and Healthcare suite of Computer System Validation (CSV) solutions ensures the quality and performance of sensitive medical systems.

Rest Assured! Medical Device Software™
Want to be certain that your medical device software lives up to your customer's expectations and complies with regulatory requirements? Did you know, since 2004, all manufacturers of medical devices must produce evidence of risk management in compliance with ISO standard 14971:2009.

Application of Risk Management to Medical Devices
In order to comply with the European Directives for placing medical devices on the market, manufacturers are required to establish documented requirements for risk management throughout product realization and to maintain records arising from risk management.
Rest Assured! Medical Device Software™ is a complete solution developed to produce documented evidence that the process of validating the software components of a medical device also complies with the ISO standard. If your organization is manufacturing or, as a user, is responsible for integrating such devices in a wider operational infrastructure, choose Rest Assured! Medical Device Software™ for complete confidence that the process of software validation is based on risk analysis addressing all hazards known or reasonably foreseeable which may affect the safety and health of patients, users, or where applicable, other persons.

Why is risk management essential for the validation of medical device software?
The purpose of risk management is to identify potential problems before they occur, so that activities may be planned and executed as needed across the life of the product to mitigate adverse impacts on the quality of products compromising the safety and health of patients, users, or, where applicable, other persons.
Software plays an increasingly important role in the quality and performance of medical devices. However, software is also one of the high-risk components of such devices. It is therefore essential to assure the validation process in a continuous process of risk management.
Risk management helps to focus the validation activities on critical issues making the process more effective and efficient.

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