General information
Thematic Technology Transfer (TTT) MedTech and regional partners Oost NL and the MedTech Twente offer access to an online platform that guides you through the regulatory principles. Principles that need to be understood at the earliest stage of innovation of a medical device, an in vitro diagnostic (IVD) device or any medical software. Ask anyone who’s been there and how it was in the first time: Finding and interpreting regulatory information takes days of flipping through the piles of regulations and guidelines to months of not knowing what to do while risking the viable direction of a product development project. This tool and the supporting online training series provide clause-by-clause references and links to the original requirements. It presents the terminology, examples and guidance from the regulatory sources in an intuitive format. It generates a personalised report and the draft Regulatory Strategy to begin your journey to the market.
Speaker
Heikki Pitkänen, CEO & Founder Digital Information Runways @ Lean Entries
Heikki has worked in health tech startups and managing roles of two Notified Bodies and accredited test labs for electromedicals, most recently at SGS. He’s been active in international standardization and has represented Finland in the Advisory Board for Healthcare Standards (ABHS) of CEN-CENELEC. He is an author of a Business Finland publication European Medical Device Regulations MDR & IVDR – A Guide to Market.
Lean Entries is on a mission to light the way into compliance and other complex information for the health tech innovators. We have worked in health tech startups, large multinational companies, Notified Bodies and accredited test labs. The Entries platform was born for turning the piles of regulatory requirements into instant actionable knowledge and to help startups save months of time in creating viable health tech. As a result we see a growing number of innovators that turn regulatory compliance into their business advantage.
Lean Entries is part of the Labquality family of companies with a common team of ca. 45 regulatory affairs, quality assurance and clinical research professionals in Finland, Germany and Poland.
Program
Workshop 1: 14 September 2023 | 15:00 – 16:30 hrs
Your regulatory strategy using digital MDR & IVDR tool Lean Entries – Part 1 of 2
In this online workshop Heikki Pitkänen will present the tools and the online training series to build the regulatory strategy for your medical device.
Upon registration, you will receive instructions to subscribe to Entries and the online training series to prepare hands-on with the tool beforehand.
Webinar session Regulatory Essentials in Health Tech: 21 September 2023-21 November 2024
Following the introduction workshop, you can attend the Regulatory Essentials in Health Tech webinar sessions online or watch the recording according to your specific needs and schedule until the end of January 2024. The program closes with a second workshop on 18 January 2024.
Workshop 2: 18 January 2024 | 13:30 – 17:30 hrs
Your regulatory roadmap using digital MDR & IVDR tool Lean Entries – Part 2 of 2
In this second and live workshop, the teams and startups pitch their Regulatory Strategy according to the model provided during previous session, while regulatory experts provide feedback. All participants are stimulated to engage and share their learnings and expertise in the discussion. If time allows, the teams will be divided into breakdown rooms based on device type to discuss their most burning regulatory challenges. The pitches are voluntary but highly recommended and a valuable conclusion of the program.
This second workshop, closes the MDR program offered by TTT MedTech and regional partners OostNL and MedTechTwente cluster. For more information of the full program, see the first workshop as well.
Sign up
Sign up via Thematic Technology Transfer.
