Health tech quality management and regulatory affairs workshop

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

Agenda:

Morning session 9–12 (Training)

• Commercializing medical devices
• MDR overview
• Quality management according to ISO 13485
• Software development according to IEC 62304
• Risk management for early stage teams

(Lunch break)
 

Afternoon session 13–16 (Group Challenge)

• Teams are split into 2-3 groups, each assigned a specific challenge related to medical device commercialization or regulatory affairs.

• Each group works on:
-Group 1: E.g. Designing initial regulatory analysis for a new medical device.
-Group 2: E.g. Identifying first quality assurance processes critical to commercialization.
-Group 3: E.g. Developing a compliance roadmap.

• Facilitators provide guidance, answer questions, and encourage strategic thinking. Labquality will provide template for the workshop.

• Roadmap presentations of each group

• Wrap-Up & Next Steps
-Summarize key takeaways and discuss how teams can apply insights to their ongoing projects.
-In addition Labquality offers 1h one to one sparring for all teams in Teams.

Workshop goals

Understanding of commercialization & regulations:
• Teams will learn knowledge on medical device commercialization, quality assurance, and regulatory affairs to navigate and apply these requirements effectively.

Skills for medtech and healthtech innovation:
• Training promotes practical skills to integrate regulatory and quality requirements seamlessly into their development cycles.

Effective regulatory strategy understanding:
• Participants will gain confidence to actively support regulatory strategies, understanding how compliance drives successful market access.

Teams will leave with actionable skills in quality assurance and regulatory matters, ready to apply best practices and drive improvements in compliance.

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Coach: Labquality’s Mikko Juuti, Rosa Tenqvall
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