News
Droplet IV achieves ISO 13485 Certification, marking major milestone toward market entry of automated IV line flushing device
Copenhagen, Denmark - April 23, 2025
Droplet IV, a Danish medical device company developing a unique and proprietary automatic IV line flushing device, has officially received its ISO 13485 certification. This internationally recognized quality standard is a critical milestone on the company’s fast-moving path to market - and comes at a pivotal moment as Droplet IV nears completion of its first investment round.
The certification marks a significant milestone towards commercialization with the company staying on track for a first product launch in 2026.
“Healthcare systems around the world are under pressure, and nurses need better tools - now. We get messages every week from nurses asking when they can get our device. ISO 13485 certification is more than just a quality milestone for us - it’s a signal that we’re moving decisively toward meeting that urgent demand.”
- Marcus Bech, CEO of Droplet IV
Since its founding, Droplet IV has secured more than DKK 20 million in funding and has been accepted into some of the world’s most prestigious MedTech acceleration programs. It is backed by an exceptional clinical advisory board, including two of the most prominent international key opinion leaders in IV infusion therapy. These achievements reflect strong validation from both the investment and healthcare communities world-wide.
The ISO 13485 certification comes at a pivotal time, as Droplet IV’s first funding round is nearing completion. With this momentum, the company is well-positioned to complete the last clinical and regulatory steps before commercialization of its innovative device.
About Droplet IV
Droplet IV, founded in 2022 and based in Copenhagen, Denmark, is a medical device company focused on developing a safe, simple, and cost-effective automatic IV line flushing solution. The company’s vision is to improve patient outcomes, reduce the time nurses spend on manual IV tasks, and eliminate unnecessary medical waste. The IV market is a $12Bn annual market and our objective is to introduce our first product to market in 2026 and scale our business in the following years.
For media inquiries or investment information, please contact:
Marcus Borum Mølskov Bech
CEO, Medical Doctor
Droplet IV
Mobile: +45 20838392
E-mail: marcus@dropletiv.com
www.dropletiv.com