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Health Tech Regulations and Quality Management – For R2Bs and startups

Name: Health Tech Regulations and Quality Management – For R2Bs and startups
Start: 2023-09-05T09:00:00+03:00
End: 2023-09-05T15:00:00+03:00
Location: Aalto Startup Center, Otakaari 5 I, A Grid, I-Wing, 4th Floor

5.9.2023 @ 09:00 - 15:00

This is an Aalto internal workshop and only for our internal community.

R2B Pre-Business Incubator is organizing a 2-days health tech regulations and quality management workshop. Target audience is Aalto Research to Business cases and Aalto Startup Center portfolio startups. Day 1 (5th September): Common training day together with all the teams Agenda: -Innovating in a regulatory industry -Commercialization of medical devices -Quality management according to ISO 13485 -Software development according to IEC 62304

Day 2 (6th of September): For selected 5 teams 1-to-1 coaching slot 45 minutes. Teams are selected based on the activity of first-day training. Slot times to be agreed separately. Agenda: -Baseline analysis -Target -Roadmap for next steps Workshop goals: -Simultaneous development of quality assurance and regulatory affairs competences, leadership, change and renewal capacity. -The aim of sparring and coaching is to ensure the accelarators ability to innovate and the ability to continuous learning, collaborating, innovating and developing. -The aim is to increase the skills and attitudes of accelarators members to support the implementation of the regulatory strategy and to gain new competences in quality assurance and regulatory affairs. -An open, knowledgeable and innovative community ensures human competitiveness and the common interests sought by action. Coaches: Mikko Juuti, Ilkka Juuso – Kasve Oy -Mikko Juuti is CEO at Kasve, PhD. Physics (Photonics) -Ilkka Juuso is D.Sc. (Tech), Information engineering Host: Joel Takala Registration opens on 1st June. Register hereby 4 September, 20.00.

This training is part of Startup Center’s Business Generator module 9: Regulations

This is an Aalto internal workshop and only for our internal community.

What do participants say about the workshop: “Best is advise on how to approach R2B projects and QMS implementation experience on a real-world project.” “I liked the 1-1 coaching, as we were able to discuss more in-depth the specific challenges that we are facing in our project.” “Understand prerequisites needed for clinical studies and ISO13485”.