Element’s Irvine testing facility specializes in medical device testing and compliance, helping manufacturers navigate the complexities of N. American and global regulations.

 

Visit the Element Irvine laboratory for their Medical Device Lunch & Learn ‘Understanding North American Medical Device Compliance’, where technical experts will present on the basics of medical IEC 60601 EMC and Safety testing, testing differences for wireless medical devices, and how to navigate N. American certification and using the ASCA FDA program. 

 

Who this event is for?

This event is ideal for professional engineers working in the field of medical device design and development, manufacture and certification. It covers the basics of medical device EMC and Safety testing for IEC 60601, implementing radio technologies into medical devices, and certification pathways and ASCA FDA program.  

Sign up or request more information 

Technical Presentations 

Attend two expert-led technical sessions designed to deliver key insights into testing and certification challenges for medical manufacturers. Presentations will cover the following topics:

  • Understanding IEC 60601 basics – EMC and Safety 
  • Radio module integration in medical device application – what you need to know?  
  • Product approval challenges, certification pathways for N. America, and FDA ASCA. 

 

Lab Tours & In-Person Q&A  

Get an up-close look at our expansive testing capabilities through guided tours of our facility, as well as in-person 1-1 Q&A with our technical experts to support your testing and compliance needs. 

 

Food & Refreshments 

Enjoy a complimentary lunch and refreshments throughout the day. Take time to network with Element engineers and industry peers. 

 

Connect with Experts 

Meet with our technical staff and ask questions specific to your organization’s needs. Learn how Element can support your product development cycles, reduce time to market, and ensure safety and performance standards are met

 

How to register 

To register yourself or your teams’ space at the event, contact us via contact.us@element.com

Robert Burek, Product Safety Technical Manager

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 in Product Safety and regulatory compliance. Bob was the TIC Council Chair for the FDA ASCA program. He was Lead Assessor and Technical Expert for the IECEE CB Scheme in the areas of medical, laboratory and information technology and audio/video equipment, and participates in the CB Scheme expert task forces for these categories.  Bob has worked in standards development for the IEC, UL, CSA and NIJ standards in the areas of medical, laboratory, information technology, audio/video, and alarm equipment. 

 

Victor Ratinoff, Certification Manager 

Victor brings more than 30 years of experience in EMC and Product Safety testing and certification, joining Element in 2009. He specializes in regulatory approvals for Medical Devices as well as IT and AV products, offering deep expertise in navigating complex compliance requirements. Most recently, Victor has led the development of Element’s NRTL/SCC program, achieving OSHA and SCC accreditations in record time. With his extensive background in certification and market access, Victor is a trusted resource for guiding even the most challenging products to successful approval. 

 
David Shaefer, EMC Technical Manager

David Schaefer is EMC Technical Manager for Element Materials Technology’s Connected Technologies business unit. He graduated from North Dakota State University with a degree in Electrical Engineering and has more than 20 years’ experience in EMC, radio, and product compliance. David was the Chapter Chair of the Twin Cities IEEE EMC Society, is active in ANSI C63 subcommittees 1, 5, 6, and 8, and is chair of C63’s Subcommittee 8 - Medical Device EMC Test Methods. He is involved in standards development, including vice chair of the working group that published ANSI C63.24, and involvement with C63.33, C63.4, C63.10, and C63.27. He has presented at the IEEE EMC+SIPI Symposium, and is a regular contributor to the Minnesota EMC Event.