Discover an informative webinar that focuses on how to navigate the complex landscape of medical device safety and necessitates understanding the standards and regulatory requirements of bodies such as the United States Food and Drug Administration (FDA).
Medical devices need to address differences between basic safety, essential performance and intended use. There are different requirements and standards for various functions, many of which need different types of testing. It can be challenging to navigate these complex requirements and to understand which requirements take precedence. This webinar is designed to help simplify this process.
Would less regulatory pushback accelerate the time to market? Is there an interest in acquiring more knowledge and guidance for this process? In this webinar, the expert speaker will discuss basic safety and essential performance requirements under the IEC 60601 series as well as the challenges in integrating power supplies and batteries into a medical device.
Join this webinar to learn about product safety for medical devices. The expert speaker will cover best practices when designing a medical device, which will help create a path to ensure a smooth regulatory process. In the USA, medical devices need to meet both Occupational Safety and Health Administration (OSHA) Nationally Recognized Testing Laboratory (NRTL) and FDA requirements, and this webinar covers how to achieve this goal.
Register for this webinar today to enhance your understanding and expertise in medical device regulation and product safety compliance.
Speaker
Bob Burek, Product Safety Technical Manager, Connected Technologies and Mobility, Element Materials Technology
Bob Burek is a Product Safety Technical Manager for Element Materials Technology’s Connected Technologies and Mobility business unit. He graduated from Northeastern University with a degree in Electrical Engineering and has over 30 years’ experience evaluating devices for Product Safety and regulatory compliance.
Bob was the TIC Council Chairperson for The FDA Accreditation Scheme for Conformity Assessment (ASCA) program, and a member of various standard development panels for medical and related devices. He is active on the IECEE CB Scheme’s Expert Task Forces for Medical, Laboratory, and Information Technology Equipment.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Medical device manufacturers
- Design Engineers/Managers
- Compliance Engineers/Managers
What You Will Learn
The attendees will gain insights into:
- Product safety requirements for medical devices
- What is essential performance and how to identify it
- Key test and construction requirements
- How to integrate power supplies and battery packs in medical devices
Xtalks Partner
Element
Overcome tough challenges and gain faster market access with Element’s advanced testing equipment and team of connected technology experts. Manufacturers of connected devices ensure compliance with regulations and reduce service failures with Element’s world-leading testing, inspection, and certification services. Develop better systems and components for the next generation devices and bring products to market faster with fast turnaround times and best-in-class service when you partner with us. Element provides end-to-end technical consulting and regulatory support from prototype to commercialization and encompasses advisory, testing, certification and inspection for carrier, industry, and government approvals, and global market access support.
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