AHMED Workshop 1

AHMED Workshop 1

Virtual Workshop Online

Thursday, November 19th, 2020

13:00 - 16:00 (Finnish time)

ARE YOU INTERESTED IN:

  • Developing and deploying software and AI solutions in fast agile cycles
  • Fulfilling safety and security regulations
  • Conforming to the coming EU’s Medical Devices Regulations (MDR & IVDR)

This workshop presents the main problems Business Finland –funded AHMED project wants to solve, in order to approach continuous regulatory compliance (RegOps). Both software engineering and machine learning (ML) viewpoints are in scope.

 

By participating the workshop you will obtain:

  • a picture what is possible today, and where the possible incompatibilities are
  • what are the key boundary conditions that regulations pose

You will also get a chance to discuss hot topics, raise questions relevant to you and give input to project’s agenda, which – for one part – aims at influencing the regulations themselves.

 

PROGRAM

1. Introduction to AHMED Project

Background, purpose and goals of the project.

Jari Ahola, Smart Health Research Team Leader, VTT

 

2. State of the art – SW DevOps and machine learning in regulatory industry

Compatibility of agile software development and MDR requirements.
Machine learning aligment with continous delivery and validation under MDR requirements.

Vlad Stirbu, Postdoctoral Researcher, Helsinki University

 

3. Case Koronavilkku – Story so far

Sami Köykkä, Senior Consultant, Solita

 

4. Workshop

Facilitated online by AHMED Project Consortium. Discussion on challenges, problems, as well as possible solutions and best practises. Priority questions shall be considered as an input to the project agenda.

Workshop Topics:

  • 1. From the old EU directive to MDR – What are the (new) challenges for fast software and AI deployment?
  • 2. Design controls processes and SW agility: Identify easy vs problematic areas. Where are the gaps for skills and tooling?
  • 3. Effective compliance and risk management for AI/ML. How to prove trustworthiness? How to accelerate approval and deployment?
  • 4. Design changes, releases and agile iterations, including changes in AI/ML implementation. How to know what kind of regulative procedure is needed for each kind of change? E.g. when an interaction with a notified body is required
  • 5. Topics raised by participants. Any other topic you would like to bring into attention?

 
You may also suggest a topic by contacting us!
You are warmly welcome – fill out the registration form below!

 

 

WHAT IS AHMED PROJECT

AHMED stands for “Agile and Holistic MEdical software Development”. Research project AHMED aims to create an approach to regulatory requirements that takes into account the processes, practices and tools of continuous software engineering. This includes identification of best recognized patterns and practices in agile medical device development following continuous software practices, as well as tools and techniques that can provide support for traceability, risk management, and verification and validation. The research covers both software engineering perspective and data science, i.e. machine learning (ML) and artificial intelligence (AI). As concrete demonstrators, partner companies and academics work on case studies that reflect actual business needs.

The project will run for two years. It is coordinated by VTT Technical Research Centre of Finland and participated by Helsinki University as well as six companies:

  • Atostek Oy
  • Bittium Oyj
  • Mylab Oy
  • Solita Oy
  • Taipuva Consulting Oy
  • Terveystalo Oyj

AHMED is partly funded by Business Finland and it is a part of  Business Finland’s Smart Life program.

Also see AHMED project’s web site: regops.fi

For more information about the project, please contact:
Jari Ahola, Smart Health Research Team Leader at VTT: jari.ahola@vtt.fi
Tommi Mikkonen, Professor at Helsinki University: tommi.mikkonen@helsinki.fi

 

 

Register to AHMED Workshop

Please make sure your email address is correct to receive participation link!

Questions?

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contact@taipuva.com

+358 50 522 8010

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