General information

TTT MedTech, together with regional partners OostNL and the MedTechTwente cluster offers you access to an online platform that guides you through the regulatory 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 anything from days of flipping through the piles of regulations and guidelines to months of not knowing what exactly to do, while risking the viable direction of a product development project. This tool and the online training series supporting it provides 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 and 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
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: 14 September 2023-31 January 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.

Workhop 2: 18 January 2024
Your regulatory roadmap using digital MDR & IVDR tool Lean Entries – Part 2 of 2
In this 2nd and live workhop, the teams will pitch their regulatory strategy based on the acquired information and bring up questions. A suggested pitch content will be provided by Heikki. Invited regulatory experts will give feedback and guide the discussion.

This second workshop, closes the MDR program offered by TTT MedTech and regional partners OostNL and MedTechTwente cluster. .