Over the next three days, MedTech professionals will be heading to the 32nd annual MD&M West Conference. While it is important for them to define design techniques and development strategies, as well as leverage the latest breakthroughs in value-based product development, it is just as important to focus on overcoming regulatory challenges.
In order to sell a medical or in vitro diagnostic (IVD) device in a particular country, it must be registered with the local regulatory agency. But without the right expertise and tools, obtaining premarket approval for devices can be a challenge — regardless of their level of risk, indications of use and technical specifications. And yet, the practice of regulatory affairs remains a fragmented, expensive and inefficient process that is managed manually, mostly through local distributors and consultants.
Regulatory intelligence and registration tool LICENSALE.COM is transforming the way medical and IVD device registration is managed. Being rapidly implemented all over the world, the cloud-based solution can be customized to fit a MedTech firm’s specific needs so it can best meet its business objectives.
With LICENSALE.COM MedTech manufacturers can:
• Reduce regulatory costs by as much as 50% and get approvals for a fixed price
• Expedite time-to-market by 100%
• Quickly gain access to 100+ markets across the globe and even process multiple market clearance applications simultaneously
• Easily control and trace past, present and future registration processes
• Retain ownership of licenses
Through LICENSALE.COM global radiation therapy giant Elekta was able to obtain regulatory approval for 78 products in 16 countries – all in less than a year. If you would like to experience this level of success, contact us today, and we’ll discuss how to transform your regulatory pathway.