Europe-based startup Flinn (www.flinncomply.com) closed a 1.8m pre-seed funding round led by Speedinvest (that just closed a 500€ Mio fund last week) and SquareOne (pre. Paua Ventures). The founders, Bastian, Markus, and Hasib have extensive experience in scaling startups, building tech products and navigating the medical industry. With the introduction of the MDR (Medical Device Regulation) in the European Union, the complexity to manage medical product compliance went through the roof and endangers medical device accessibility on a global scale. Thus, Flinn provides a Software-as-a-service solution for medical device manufacturers and the pharmaceutical industry to make compliance processes 10x more efficient.
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The accessibility of critical medical products is at risk and processes are done very manual today
‍Since 2021 all new medical products released on the European market have to comply with the new Medical Device Regulation (MDR). With this change, the EU introduced the most sophisticated regulatory framework around medical products worldwide, to react to certain short-comings in the last decades. While the regulation is meaningful around its purpose to ensure the highest safety standards, it heavily increases the complexity and costs for medical device manufacturers. They are unable to hire qualified people to compensate addition efforts, so they are forced to:
* cut highly relevant but less profitable niche products like pacemakers for kids
* pull back from less profitable markets—challenging in particular medical care in developing countries

In addition, many companies are planning to launch new products on the US market first, which is going to shift more innovation away from Europe. Thus, medical product accessibility on a global scale is suffering.However, Flinn does not only work on solving the issues coming from the MDR regulation, but generally helping the heavy underdigitalized MedTech and Pharma industry on workflow improvements. This means to fully digitalize processes, that are today highly manual, sometimes even pen and paper based.

Flinn provides a Software-as-a-service solution for medical device manufacturers to make compliance processes 10x more efficient.
The software simplifies the quality regulatory affairs management and help to orchestrate all processes from one tool. The first product offering focuses on AI-enabled automation of major parts of the data collection, evaluation, and reporting. In comparison to other solutions, Flinn is very modular and integration friendly to allow their customers to maximize on flexibility and innovation.

‍The three founders share a common history at N26 and bring a set of highly divers skills with a proven track-record in disrupting highly regulated industries.
Bastian has over 6 years of experience in business roles in the medical industry with strong regulatory exposure. Markus has led and scaled product and tech teams from 1 to 100+ people in companies like N26 or Circ (acquired by Bird). Hasib is a highly experienced software engineer and leader, with a strong entrepreneurial background.Flinn is headquartered in Vienna, but is remote first and sets a strong focus on creating a deeply product-led culture with empowerment of highly talented people.

‍The 1.8m funding round is led by two best in class pre-seed funds who bring relevant experience and network.
‍SquareOne (pre. Paua Ventures) being entirely focused on pre-seed B2B SaaS and Speedinvest with strong expertise in the health sector. 10+ business angels with relevant medtech & regulatory affairs expertise are complementing the round.

Quote from Andrea Zitna, Partner for Health Investments at Speedinvest:”egulatory, quality and compliance processes within medtech and pharma are some of the most important but also the least transparent and automated processes to manage. With the introduction of the MDR in the EU, the (already high) cost and complexity, to companies to launch and manage medical products has skyrocketed. We are excited to back Flinn on their mission to change that!”

‍Quote from Federico Wengi, Partner at SquareOne (before Paua Ventures):”We are very excited to partner with Bastian, Markus and Hasib in their quest to build a category defining company in the field of compliance tech. We know Markus since 8 years and it is for us very rewarding to partner with former SquareOne analysts when they start new companies."