Health tech regulations and quality management
Target audience is Aalto Research to Business cases and Aalto Startup Center portfolio startups related to health and technology.
Day 1 (1st Oct): Common training event for all teams
-Innovating in a regulatory industry
-Commercialization of medical devices
-Quality management according to ISO 13485
-Software development according to IEC 62304
-Atlassian as tool for MDSW development environment
-Case examples on medical devices and softwares
Day 2 (2nd Oct): 1-to-1 for selected 5 teams
1-to-1 coaching slot 45 minutes. Teams are selected based on the activity of the first-day training. Slot times to be agreed separately.
Agenda:
-Baseline analysis
-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 ability to innovate and the ability to continuous learning, collaborating, innovating and developing.
-The aim is to increase the skills and attitudes of participants to support the implementation of the regulatory strategy and to gain new competences in quality assurance and regulatory affairs.
Coach: Labquality’s Mikko Juuti, Terhi Heikkinen
Host: Joel Takala
This is an Aalto internal event and only for our internal community.
Training is part of the Business Generator module: Technology readiness
—
What do previous training 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”.
Day 1 (1st Oct): Common training event for all teams
-Innovating in a regulatory industry
-Commercialization of medical devices
-Quality management according to ISO 13485
-Software development according to IEC 62304
-Atlassian as tool for MDSW development environment
-Case examples on medical devices and softwares
Day 2 (2nd Oct): 1-to-1 for selected 5 teams
1-to-1 coaching slot 45 minutes. Teams are selected based on the activity of the first-day training. Slot times to be agreed separately.
Agenda:
-Baseline analysis
-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 ability to innovate and the ability to continuous learning, collaborating, innovating and developing.
-The aim is to increase the skills and attitudes of participants to support the implementation of the regulatory strategy and to gain new competences in quality assurance and regulatory affairs.
Coach: Labquality’s Mikko Juuti, Terhi Heikkinen
Host: Joel Takala
This is an Aalto internal event and only for our internal community.
Training is part of the Business Generator module: Technology readiness
—
What do previous training 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”.