Free Online Medical Device Development Seminar - Sharpen your skills 2024 - Part 1
Monday May 27th, 2024 | 13:30 - 16:30 CET | Free Online Medical Device Development Seminar
Compliant and Efficient Medical Device Development
An impossible combination?
We provide concrete and practical advice on how to meet common and urgent medical device development challenges.
Meet our group of experienced industry experts to share their latest best practices on how to eliminate problems with you.
Register now to reserve your seat!
Register on Linked In: Click here
We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to
Key Learning Objectives
Agile and SaMD development – pitfalls to avoid!
Many organisations fail to fully utilise Agile methodologies while developing SaMD products.
This talk will discuss the "dos and don'ts" of using Agile for medical device software development.
Agile can improve design control and save time and resources when used correctly.
By: Christian Kaestner, co-author of IEC 62304 and IEC 82304-1, expert at Medical Device HQ
Tales of Tangles and Triumphs: Navigating the Pitfalls of Medical Device Development
In this talk, we'll explore the importance of adaptable business requirements, demonstrated by a diagnostic device project, where not anticipating market evolution results in dramatic consequences.
We'll delve into the cautionary tale of a failed Model-Based Systems Engineering (MBSE) implementation, hindered by over-reliance on a complex modelling language known only to a 'chosen one,' spotlighting the critical need for accessible and common understanding in project teams.
Highlighting a project ensnared in an extended testing phase due to initially untestable requirements, I'll share insights into the pivotal role of early-stage validation to prevent costly delays and ensure a smooth path to market approval.
By: Pierfelice Ciancia, Business and Systems Engineering Consultant, Ciancia Consulting Partners
Around the globe – Med Tech Usability evaluations in an international context
The regional regulation and definition of standards to be complied with is constantly increasing, also in the field of medical usability engineering.
The latest publication of the Human Factors guidance of the Chinese NMPA illustrates this trend.
In this knowledge infusion, Dr. Benedikt Janny, compares existing international guidelines and elaborates how to validate when addressing different international markets.
By: Dr. Benedikt Janny, Head of Usability Engineering at USE-Ing. GmbH,
7 reasons why Risk Assessments are horrible - and how to tackle them
Risk Assessment can be terrible! They can be ambiguous, exhausting and leave you both drained and frustrated.
Remaining is that uneasy feeling, not knowing if you have gone deep enough and whether what you have entered makes sense to anyone else than yourself.
In this seminar, I will share how I learned to stop worrying and love (well, not quite!) Risk Assessments.
By: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG
Time and Place
- Date: Monday, May 27th
- Time: 14:30 - 16:30 CET
- Live Streamed from the Aligned HQ. The Teams link is on the Linked In Event page.
Presentations are held in English.
Target audience
This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.
Registration
Register to get your online access. We are looking forward to seeing you in this virtual seminar!
About Aligned AG
Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence.
This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.
