DÜSSELDORF, Germany (PRWEB) November 07, 2018
Emergo by UL, a global consulting firm supporting medical device, IVD and network-connected healthcare technology companies to meet market compliance, cybersecurity, and human factors research and design objectives, plans to provide no-cost, one-on-one meetings with subject matter experts during the 2018 Medica medical trade conference to be held November 12th through 15th in Düsseldorf, Germany
Medica attendees may be scheduled now with Emergo by UL experts in Hall 16, Booth D32-9.
Evolving medical device and IVD regulatory requirements present the biggest business challenges perennially for both large and small manufacturers alike; Emergo by UL’s 2018 medical device industry research shows that regulatory issues continue to pose major challenges to manufacturers in the US, Europe, Japan, China and other markets worldwide. Emergo by UL consultants and market experts will be available during the four-day Medica conference to discuss topics such as:
- European Medical Devices Regulation (MDR) and In-Vitro Diagnostic Medical Devices Regulation (IVDR) compliance
- US FDA 510(k) Premarket Notification and other US registration pathway requirements
- Regulatory considerations for digital health technology products
- FDA QSR, ISO 13485:2016 and other medical device quality management system requirements
- Medical device and IVD regulatory requirements for markets including Japan, China, Brazil, Mexico and South Korea
- Clinical investigation and data requirements as well as Clinical Research Organization (CRO) support
- Human factors engineering (HFE) and usability considerations
Medica is the world’s largest medical tradeshow, drawing more than 5,000 exhibitors globally in 2017.
About Emergo by UL
Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. We help device companies meet registration requirements in the world’s biggest markets. With a team of experienced RA/QA consultants working across the globe, we can assist with device registrations, quality management system implementation, in-country representation, clinical study compliance, human factors research and design, and more. Learn more at EmergobyUL.com.