Risk management helps device manufacturers


Medical device companies can improve time to market, enhance lifecycle revenue and avoid compliance issues through a strategy of risk management and a firm understanding of developing regulatory standards, according to a white paper released by software design company RTEmd.

The white paper states that as hospitals and healthcare providers are seeking to more efficiently treat patients in a cost effective manner and medical device companies are looking to increase usage and effectiveness of devices, device connectivity offers significant opportunities and associated risks for all stakeholders. It discusses the most common errors and strategies for reducing risk and optimizing performance when developing and implementing a medical device connectivity strategy.

“Device connectivity requires shared responsibility between the device developer and the user environment. To optimize user value, and revenue for the manufacturer, while insuring privacy and data security, the developer must have a thorough understanding of applicable standards, practical integration experience and an effective mechanism for integration testing and documentation,” said Bob Ruppenthal, RTEmd president.

“Our new white paper shares some of the knowledge gained from our extensive work integrating devices into LIS systems, lab automation systems, cloud-based architectures and with the OEM service and support teams for remote diagnostics.”



RTEmd, Medical device companies, risk management