Join us on September 22nd for our virtual conference and see how other startups became compliant. It's free!

OpenRegulatory Conference 2021

A conference to connect startups, share solutions, conquer regulatory challenges and learn from the greatest in our field.

September 22, 2021
That's a Wednesday. Talks start at 10:00 Berlin time. The official end is at 17:00 with open-ended networking sessions.
Online & Free
The conference will take place online and is free for everyone!
Virtual Networking
You'll have lots of opportunities to meet other people working in Healthtech.
No boring talks
Startups share stories on how they overcome regulatory hurdles, and experts will share the latest and greatest. Live demos included.
Register Now, It's Free!

Also, add it to your calendar: Google, iCal, Outlook.

Are you bored by regulatory conferences and unsatisfied with abstract talks?

The OpenRegulatory Conference on September 22nd, 2021, will be the first of its kind to provide concrete presentations on how Healthcare startups solved their regulatory problems.

In addition, top-level experts will provide you with the latest news and updates in the regulatory field, so that you can be compliant today and tomorrow.

We'll focus on simple solutions, presented by great speakers. Things which will help your compliance work at your company.

Completely free, fully remote and with lots of opportunities for virtual networking!

Schedule

September 22nd, 2021

10:30 - 10:50

Introduction

Dr. Oliver Eidel, OpenRegulatory

10:50 - 11:15

Common Findings in SaMD Applications and Notified Body Expectations

Natascha Cuper, Kiwa Dare Services

11:15 - 11:55

Lightning Talks (10mins each)

What's so hard about building Medical Devices for consumers?

Jouke Waleson, easee

Using git for QMS Document Control

Dr. Johannes Tanne, dentalXrai

Internal Audit in a Nutshell

Ben Meier, Curalie

Software Requirements Management

Ivo Flipse, Zimmer Biomet

12:05 - 13:00

Virtual Networking & Lunch

13:00 - 13:40

Lightning Talks (10mins each)

Agile Development of Medical Devices

Dr. Oliver Eidel, OpenRegulatory

Risk Management in Decision Support Systems

Leon Doorn, Aidence

Medical Device Software and IVDR

Dr. Anja Kassner, RoX Health

Supplier Evaluation of Medical Annotators for AI SaMD

Astrid Ottosen, Radiobotics

13:45 - 14:30

Digitalization of Technical Documentation

Martin Witte, TÜV SÜD

14:30 - 15:00

Ask Questions About the Talks

15:00 - 15:15

Break

15:15 - 16:00

Discussions (in parallel)

Requirements Management

Moderators: Ivo Flipse, Oliver Eidel

Technical Documentation

Moderator: Jouke Waleson

Risk Management in SaMD and IVD

Moderator: Sven Piechottka

AI-based Medical Devices

Moderator: Leon Doorn

16:00 - 16:45

An AI Medical Device Global Status Update (ISO, IMDRF, Legislation)

Pat Baird, Philips

16:45 - 17:15

Wrap-Up and Open-End Networking

Pat Baird, Philips

An AI Medical Device Global Status Update (ISO, IMDRF, Legislation)

Pat likes to think of his job as “Policy Engineering” – understanding the unmet needs (and frustrations) of regulators and developers, and developing standards, whitepapers, and training to meet those needs. He co-chairs over 10 committees at AdvaMed, AAMI, MITA, Xavier, CTA, and others on topics such as agile software development, cloud services for a regulated environment, and multiple committees on artificial intelligence in healthcare.

Natascha Cuper, Kiwa Dare Services

Common Findings in SaMD Applications and Notified Body Expectations

As the first applications for MDR certification have been submitted and the first certificates have been issued, it becomes more clear what manufacturers of SaMD are typically struggling with. In my talk, I will lead you through some common findings we see as a Notified Body and will tell you what our expectations are. This way, start-ups might be able to avoid these errors, helping them to go more smoothly through the certification process.

Jouke Waleson, easee

What's so hard about building Medical Devices for consumers?

Technology can help in offloading the pressure on the healthcare, by allowing users to diagnose, monitor or prevent health issues themselves. However, building such medical devices is surprisingly hard. In this mini case-study we'll show you how easee approached the business, technology, usability and certification of their online eye exam which can be used by lay-users without any training.
Since 2018, Jouke Waleson is CTO at easee, the SaMD online eye exam company based in Amsterdam. Jouke has a background in software development and product management at Mendix. After completing the MDD certification at easee he started the European SaMD meetup group to build a network of medical device professionals that are willing to share information and help each other.

Ivo Flipse, Zimmer Biomet

Software Requirements Management

By storing your requirements and specifications in text-based files, you can generate up to date documentation, produce flawless trace matrices, leverage version control software during change management and integrate nicely into the software development workflow.
Ivo is Project Manager at Zimmer Biomet where he works on preoperative hip planning software since 2014. Through trial and even more error he has gained a lot of experience in how to avoid the pitfalls of developing SaMD. Resulting in two successful 510k submissions and several audits without (major) findings.

Dr. Anja Kassner, RoX Health

Medical Device Software and IVDR

Depending on the purpose intended by the manufacturer, software may qualify as a medical device. However, determination of software needs to cover not only potential qualification as a medical device but also further analysis to allow the appropriate classification according to MDR or – potentially - even IVDR.

Dr. Anja Kassner has a history in design and development as well as regulatory affairs of medical devices of different risk classes including recent hands-on experience in successful implementation of MDR requirements for manufacturer of standalone software devices. Currently, she is a team member of RoX Health GmbH and works with selected digital health start-up companies in regulatory compliance projects.

RoX Health GmbH, based in Berlin, is a company builder and accelerator in the field of digital health solutions and a subsidiary of the Roche Deutschland Holding AG. RoX Health focuses on the German healthcare market and provides founders and start-ups with its expertise in the healthcare sector with the aim of ensuring that their solutions are reimbursed by health insurance companies within the framework of the Digital Health Care Act (DVG).

Dr. Oliver Eidel, OpenRegulatory

Agile Development of Medical Devices

Currently, regulatory-compliant software development causes major headaches. Initially, software is developed and code is written. But then, everyone goes crazy, because now they have to create documentation! This sounds a lot like waterfall development, but it's actually much, much worse.

Other fields have made much progress when it comes to management of software projects. You know, all that agile stuff. But can software as a medical device be developed in an agile way? And if so, how would an implementation look like? I'll talk about lessons learned from my consulting experience and which tools to use.

Oliver is a Medical Doctor, Software Developer and Regulatory Consultant. He founded OpenRegulatory (the website you're staring at) after consulting Healthcare companies and seeing that the field is full of good intentions with bad implementations. Prior to founding OpenRegulatory, he worked at Vara where he was part of the team which developed Germany's first AI software and got it certified as a Medical Device.

Martin Witte, TÜV SÜD

Digitalization of Technical Documentation

The medical device industry is among the most innovative industries and is leading in finding technically advanced solutions for improving patient’s life. However, our ecosystem sometimes lacks effective digitalization, especially when it comes to setting up a Technical Documentation smartly. Traditionally Technical Documentations were created as binders filled with paper. This has definitely changed over the past years, today the typical method is a collection of PDFs or one huge PDF provided in a digital folder structure.

This approach can be understood as "Digitization", not "Digitalization". "Digitalization" would result in improved data usage and in a boost of efficiency. Digitalization requires a lot of preparation and investments. Learn about the notified body’s point of view towards digitalization and get inspired about how you can benefit from a smart data structure in your daily work life.

Martin Witte is Senior Director Strategic Business Development for the Medical Health Service business at TÜV SÜD and responsible for strategic topics such as Active Medical Implants, Cardiovascular, Orthopaedic, and Functional Safety/Software.

Prior to his current role, Martin was a Lead Auditor and Product Specialist for high risk devices. Prior to TÜV SÜD Martin worked on the industry side for 6 year as a Regulatory Affairs Manager with BIOTRONIK focusing on heart rhythm management devices and MRI safety of active implantable devices. Martin is a strong supporter of digitalization in the Medtech world.

Dr. Johannes Tanne, dentalXrai

Using git for QMS Document Control

Git can be used for the documentation process for medical device manufacturers, especially medical software manufacturers. The presentation will focus on the possibilities of using the version management tool to enable easy traceability and structured document control. As it is already used in the best practice of software development and is common standard in a good software development process.

The documentation not only enables the creation of markdown files, but also helps the user to easily version manage individual documents. This includes documentation from QM master documents, QM records to essential technical documentation records so that documents such as software architecture can be easily kept up to date by developer staff and are auditable for certification audits.

It will be shown how documentation can be realized from creation, review of documents and records to release.

Dr. Johannes Tanne is regulatory affairs manager/ QMR at dentalXrai GmbH. He completed his master's degree in the field of biosystems engineering/ bioinformatics and his doctorate in the field of bioanalytics at the Fraunhofer Institute for Biomedical Engineering. He has several years of experience in the field of quality management and regulatory affairs and has been working as a consultant for various medical device manufacturers for the last 7 years. He is an active member of the WHO working group FGAI4H and serves on the Special Committee AI (Artificial Intelligence) and X-ray Image Analysis of DIN.

Leon Doorn, Aidence

Risk Management in Decision Support Systems

Many software systems in the medical devices field are supportive in decision making processes. This introduces a number of challenges, for example how do you effectively estimate probability of occurrence, if your device is not the single contributary cause of occurrence? Also, what can we learn from the post market surveillance process, and how should this interact with the risk assessment?
Leon is Head of Regulatory Compliance at Aidence where he is responsible for Quality, Regulatory and Information Security. He has over 14 years of experience in the medical device quality and regulatory affairs field and is a member of the ISO SC42 AI committee, working on ISO standards.

Ben Meier, curalie

Internal Audit in a Nutshell

Internal Audits are useful as they can reveal your organization's gaps in fulfilling QMS requirements before external auditors notice them.

Since my start as internal auditor for our QMS, I gained some useful learnings. I want to share some best pactices on arriving at "good findings", improving your organization and making every auditor's life easier.

Ben graduated from TU Berlin as an Electrical Engineer. He first got started in the field of Regulatory Affairs by joining Biotronik as Regulatory Affairs Manager. Now, he's the Quality Management Officer and Head of QM/RA at curalie, a Berlin-based digital health platform.

Astrid Ottosen, Radiobotics

Supplier Evaluation of Medical Annotators for AI SaMD

As a SaMD-manufacturer that develops machine learning based devices, we are heavily reliant on training data including training labels, i.e. image annotations of high quality in order to ensure a good and reliable performance of the medical device in the end.

As we use suppliers for the task of annotating the medical images, this puts weight on the supplier and purchasing process. How do we make sure that the image annotations are of sufficiently high quality?

Astrid Ottosen graduated from the Technical University of Denmark in 2016 with a master’s degree in biomedical engineering. Astrid gained experience within the field of quality assurance and regulatory affairs for SaMD as a Product Quality Engineer at 3Shape, before joining Radiobotics as the 7th employee.

At Radiobotics, Astrid is a leading figure within RA/QA and played a big part in the establishment of Radiobotics’ QMS and achieving ISO 13485 and MDR certification of it.

Organizers

We've seen regulatory requirements cause huge problems for startups and want to facilitate open sharing of knowledge. We've organized this conference in our spare time.

Leon Doorn, Aidence

Leon is Head of Regulatory Compliance at Aidence where he is responsible for Quality, Regulatory and Information Security. He has over 14 years of experience in the medical device quality and regulatory affairs field and is a member of the ISO SC42 AI committee, working on ISO standards.

Metehan Ağaca, Quin.md

Metehan is currently working as the Regulatory Lead at Quin. He did work in product/research development and in conformity asessment for a Notified Body in Europe.

Sven Piechottka, OpenRegulatory

Sven initially joined IBM to help leverage Healthcare innovation projects across Germany. Afterwards, he gained most of his regulatory experience while working for Vara, where we he built up a ISO 13485 - compliant Quality Management System from scratch while coordinating regulatory affairs, leading the ISO 13485 and CE certification of an AI-based radiology software, and serving as data protection and quality management officer. At OpenRegulatory, he helps companies set up their Quality Management Systems and consults them on data protection questions.

Dr. Oliver Eidel, OpenRegulatory

Oliver is a Medical Doctor, Software Developer and Regulatory Consultant. He founded OpenRegulatory after consulting Healthcare companies and seeing that the field is full of good intentions with bad implementations. Prior to founding OpenRegulatory, he worked at Vara where he was part of the team which developed Germany's first AI software and got it certified as a Medical Device.

Register Now for the Conference!

Register Now, It's Free!

Also, add it to your calendar: Google, iCal, Outlook.

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