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We are very excited about all the participants that joined us during our most recent seminar!

Aligned's Sharpen Your Skills event proves to be worth a visit once again!

Find the recordings of the four expert sessions below. See you again in the fall!

Session Recordings

How to transform a PMCF study to a business opportunity

Presented by: Mikaël Chelli, MD, MSc, Co-founder, EasyMedStat

Artificial intelligence (AI) Medical Devices on the EU market under MDR – impossible! Or is it?

Presented by: Roger Abächerli, Main Lecturer and Professor for MedTech, Institute for Medical Engineering IMT, HSLU

Navigate the risk management maze: Benefit-risk analysis made easy

Cristina Barkman, co-author of ISO 14971:2019 and ISO/TR 24971:2020, senior consultant at QAdvis AB

Traceability - If you don't know where you're going, you are probably not going to get there

Presented by: Anders Emmerich, MSc, CEO and co-founder of Aligned AG

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November 23rd, 2021 | 15:00 - 17:15 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: https://www.linkedin.com/events/6861944311781588992/

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.. 

Key Learning Objectives

SaMD Development is easy, right?

Developing a software-only medical device is by many perceived as complicated and sometimes even overwhelming! The rigid regulations and numerous standards governing medical device development seems to stand in stark conflict with the rapid-evolving design practices and emerging technologies that lie at the heart of software development.   

In this webinar, we will compare and contrast the development of SaMD devices with more traditional medical devices. You will learn how to handle challenges unique to SaMD development, in the large and small.

Presented by: Christian Kaestner, co-author of IEC 62304 and IEC 82304-1, expert at Medical Device HQ 

No Risk, No Fun - More Risk, More Gain!

To develop and maintain a risk management file always means a lot of effort. How can we ensure that we get the maximum gain for this effort? 

Join us for a deep dive into medical device risk management, its principles and the underlying intentions, and present an approach how to implement state-of-the-art risk management for medical devices. Make no mistake: risk management remains a large effort if you follow this approach. However, with a deeper understanding you will be able to leverage more from this effort, and will experience that risk management sessions may be fun!

Presented by: Dr. Dirk Hüber, Head of Quality, Congenius

Two for the price of One - Using Task Flow Analysis to create your IEC 62366 Use Scenarios 

Use Scenarios are the starting point of any IEC 62366 driven usability effort when applying Human Factors and Usability Engineering to medical devices.

But what method shall I use to identify and structure the Use Scenarios for my medical device?

Discover Task Flow Analysis, an efficient and collaborative technique used in several industries to not only identify and describe critical tasks, but also as a useful tool to uncover usability related hazards. This method elegantly describes the context in which the device is used and has a number of benefits that will accelerate your medical device development documentation. 

Learn from this session about the processes, techniques, and tool support available for successful IEC 62366 Use Scenario design.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG

Time and Place

• Date: Tuesday, November 23rd
• Time: 15:00 - 17:15 CET
• Live Streamed from the Aligned HQ. Sign up to get your access link!

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.

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Das Aligned Team ist am 14. und 15. September 2021 auf der Swiss Medtech Expo.

Wir laden Sie herzlich zu einer guten Tasse Kaffee und einem Gespräch über die neusten Trends in der Dokumentation von Medizinprodukten ein.

Sie finden uns in Halle 2 auf dem Stand E 2139.

Auch sollten Sie auf keinen Fall den Vortrag von Aligned Managing Director Karl Larsson zum Thema Find and eliminate errors in your Technical Documentation versäumen.

Dieser wird am Mittwoch, 15. September um 11:00 Uhr im Rahmen des Innovation Symposium stattfinden. Wir freuen uns auf Sie!

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We are very excited for the big turn out on the 2021 edition of Aligned's Sharpen Your Skills event! It was a great show and a great crowd!

Find the recordings of the five expert sessions below. See you again next year!

Session Recordings

The secret life of Medical Device Development

Presented by: Mike Heald, CEO, Commala Ltd.

Demystifying software risk management

Presented by: Christian Kaestner, co-author of IEC 62304 and IEC 82304-1, trainer at Medical Device HQ

Human-centered development as a driver of medical product innovation

Presented by: Dr.-Ing. Benedikt Janny, CEO, USE-Ing. GmbH

EUDAMED - how bad can it be?

Presented by: Richard Houlihan, CEO, Eudamed Ltd, former technical manager for Eudamed 2 and MDR EUDAMED July 2017 - April 2019

Finding, eliminating, and avoiding errors in Design Control Documentation

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG

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April 13th, 2021 | 09:00 - 12:15 | Free Online Medical Device Development Seminar

Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2021.

We have called on a 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: https://www.linkedin.com/events/freeonlinemedicaldevicedevelopm6773634480822353921 

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.. 

Key Learning Objectives

The secret life of Medical Device Development

Let me take you on a holistic walk through the act of developing a medical device, joining dots rather than picking on a discrete activity.
There is a lot of common sense that underpins the regulation but it seems lost in both presentation and interpretation.
Taking a step back and asking: “Why are we doing this?” can help you to see the woods beyond the regulatory trees.

Presented by: Mike Heald, CEO, Commala

Demystifying software risk management

Medical device software risk management is often perceived as complicated to understand and work with – it is not!
In this seminar, you will not only get the foundational understandings, but you will also understand how to practice medical device software risk management!

Presented by: Christian Kaestner, co-author of IEC 62304 and IEC 82304-1, trainer at Medical Device HQ 

Human-centered development as a driver of medical product innovation

If you want to create medical devices that people love, then usability, user experience (UX), and ergonomics is the road forward.
We will describe how you can establish a human-centered development process and how using prototypes with real users during the early stages can provide new and powerful insights.
We will explore the usability and human factors engineering regulatory underpinnings and their relation to ISO 13485.
We will dissect which types of use-related risks exist and how they can be analysed according to ISO 14971 during your product development.

Presented by: Dr.-Ing. Benedikt Janny, CEO, USE-Ing. GmbH

EUDAMED - how bad can it be?

If you thought you had covered Eudamed by implementing UDI's, then think again!
In this talk, we will address the deliverables required by medical device manufacturers, how to use medical device codes, how to communicate with the Eudamed servers.
We'll describe how to deal with legacy devices and how you can best organize your work to efficiently meet the Eudamed challenges ahead.

Eudamed is coming for you. We will help you prepare.

Presented by: Richard Houlihan, CEO, Eudamed Ltd, former technical manager for Eudamed 2 and MDR EUDAMED July 2017 - April 2019 

Finding, eliminating, and avoiding errors in Design Control Documentation - before audits and submissions

Having spent years developing and documenting a medical device just to get it rejected by a Notified Body or the FDA is a costly and disheartening experience.
Are there other ways than lengthy reviews to find and eliminate inconsistencies in your Technical Documentation?
Learn from this session about strategies, techniques, and methods for finding, eliminating, and avoiding errors in your Technical File.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG

Time and Place

• Date: Tuesday, April 13th
• Time: 09:00 - 12:15
• Live Streamed from the Aligned HQ. Sign up to get your access link!

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.

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On Thursday this week (Thu 11th, 1:30 PM - 2:30 PM), our CEO Anders Emmerich, talks at the "Mindset Impossible?" online event about the history, trends, and patterns in the digital transformation currently sweeping the medical device industry.

You can join this zoom - event. Register and get log-in details here.

The event is hosted by Digital Chameleon, a consultancy for digital transformation in the healthcare and life science sector.

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As of April 2020, we offer Aligned Elements as a Hosted solution as a complement to our existing deployment options. It is thus now possible to deploy the Aligned Elements server On-Premise, in your own Cloud, or have it hosted by us. 

The Hosted Solution will be a welcome option for our medical device manufacturing clients that do not have or are not in a position to engage, IT infrastructure and/or IT personnel.

We host your Aligned Elements database server, web application, and system integrations in the cloud on the reliable Microsoft Azure platform, applying your unique configuration of Aligned Elements, designed to match your QMS, development process, and document templates. 

Use your standard browser to access the Aligned Elements web client and allow your team to break free from technical considerations and focus on their medical device development. Automatic maintenance and monitoring are continuously performed by our experts.

As new versions of Aligned Elements are released, each client decides on when the new versions shall be deployed. A client's solution will only be updated upon explicit request in order to deliberately move from one validated application state to another. 

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We are very thankful for the engaging participation of all medical device colleagues in this year's Sharpen Your Skills event.

Videos and Slides

Perspective of Post-Market Surveillance under MDR

Download slides here.

Presented by: Linda Ahnen, PhD, Project Associate, Medidee

When to test what and why. A true story from a developer’s perspective. 

Download slides here.

Presented by: Dr. Thomas Degen, Dozent, Institut für Medizintechnik, Hochschule Luzern

Software Development According to IEC 62304 - A Real-World Perspective

Download slides here.

Presented by: Matthias Steck, Senior Consultant SW Development & Cyber Security, ISS AG

Hit by a laser – Risk Assessments Management at Ziemer Ophthalmic Systems AG

Download slides here.

Presented by: Reto Sigrist, Project Manager, Ziemer Ophthalmic Systems AG

Are we there yet? Using KPIs to track Technical File progression

Download slides here.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG

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In just a few weeks you can meet us at MedConf2020 in Munich!
If you do not want to travel that far, you can benefit from this year's Hybrid event! All participants can follow the lectures and keynotes remotely just as well as on-site!

On Thursday, October 23. 13:30 - 14:15, our Design Control Management Expert Karl Larsson will present "The hidden treasure in your Technical Documentation".