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Essential principles of Safety and Effectiveness for medical devices

222 pages
Arcler Education Inc
The medical device sector is growing fast. Every day new technology which is both complex and smart are being added to the industry. Ensuring safe and effective use of medical devices for patients and users of the device itself is a crucial responsibility for manufacturers. When designing and manufacturing medical devices, safety, and efficacy should be of utmost importance. A manufacturer should never compromise on the clinical safety requirements of its users, patients or any other persons involved. Generally, the design of a medical device is regulated by the essential principles (EP) of safety and performance. What this means is that if a device is designed to relieve pain, the manufacturer must be able to clinically prove that the device can in fact relieve pain. Often this poses a great deal of challenges to manufacturers; however, building in appropriate safety and risk management functions across a device's lifecycle is imperative if they wish to reduce the risk of post-market problems. This volume aims to provide an overview of the harmonized essential principles that must be achieved in the design and development of medical devices. It provides an in-depth explanation of the relevant medical device regulations in Europe with a specific focus on the safety and performance requirements for medical devices.
Author Bio
Shalinee Naidoo is currently the Regulatory and Product Development Manager of a medical device manufacturer based in South Africa. She is directly involved in global regulatory compliance and the design and development of new medical devices from idea conception to market. She is also the founder of Life of Shal (www.lifeofshal.com) an online travel journal created to inspire others to explore the world and Scientist’s Sanctuary (www.scientistssanctuary.com) – a science communication company that specializes in bridging the gap between scientific knowledge and creative communication for both the academic and corporate world.