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  • 作家相片Henry Sung

Masterclass held for Taiwan's startups: MDR & IVDR Compliance as a Business Advantage

On December 15, 2021, the “Mastering the Health Tech Business: MDR & IVDR Compliance as a Business Advantage” Masterclass webinar was successfully held. Organized as a collaboration between NBRP Academy, Biohub Taiwan and Tiger Accelerator, the event featured the presentation from Heikki Pitkänen, CEO & Founder, Digital Information Runways at Lean Entries - part of Labquality.

With 20 years of experience spanning across multiple startups, notified bodies, and now as founder/CEO of a regulation consultancy service company, Pitkänen shared his extensive knowledge and insights regarding the various International and European regulations that concern medical devices and products.

During the Masterclass, Pitkänen provided an overview on how startups need to approach MDR, IVDR, and other European regulations, highlighting the several key principles and concepts startups need to pay attention to. Importantly, Pitkänen emphasized that startups need to incorporate regulatory compliance considerations into the company's business strategy and product strategy from an early stage, in order to achieve smooth, efficient and timely market entry. Furthermore, regulatory compliance also needs to be taken into account at each step throughout the products' life cycle.

Throughout the presentation, Pitkänen also drew from examples of various existing startups and product types, to illustrate how companies can approach regulatory compliance in real world scenarios.

In the future, Tiger Accelerator will continue to organize webinars and other online events that connect knowledge and expertise between the startup ecosystems in Europe and Taiwan. Please follow Tiger Accelerator on our official website and social media, to stay updated on our latest activities and developments.


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