The Startup Day is primarily aimed at young companies with a concrete idea but no medical or IVD medical device on the market.
At this event, beginners, startups, and those interested in medical and IVD medical devices will gain an initial insight into the regulatory world.
Our objective is that you will take home with you a sound knowledge of topics such as project, personnel, time and cost planning, financing options, and basic regulatory guidelines for medical and IVD medical devices and be able to assess where you need to start.
The Startup Day is an intensive teaching and experiential format where you will learn how to quickly and safely turn your idea into a medical or IVD medical device. Our expert team will guide you through all the essential phases of the product life cycle through a mix of short presentations and interactive exercises.
In addition to presentations and exercises, our regulatory experts will hold several Q&A sessions on various topics to answer your individual questions directly. That will allow you to clarify any uncertainties and find the optimal solution for your situation.
Our Medical Device Days will take place at the same venue as Startup Day. Take advantage of the breaks between sessions and the evening event to network with experienced medical device and IVD manufacturers, notified bodies, and our team.
In a spacious training room, you will pass through three important stages to approve your medical or IVD medical device. Step by step, you will acquire the knowledge you need to bring your device to market quickly and safely.
1. Intended Purpose:
2. Qualification/Classification:
3. Conformity Assessment Procedure
4. Development Process and Early Involvement in the Approval Process for Medical Devices
5. Stakeholder Requirements vs. Hardware and Software Requirement Specification
6. Interaction Between Product Development according to ISO 13485 and Risk Management according to ISO 14971
7. Design and System Architecture, Interface Definition
8. Development Plan and Test Planning
9. Verification: What testing options are available?
10. Validation:
11. Prerequisites, Sequence, Dependencies in a Regulatory Project
Please note: Startup Day 2025 will take place as part of this year's Medical Device Days. The event will be hosted in German.
Take advantage of this opportunity to get advice on regulatory issues relating to your new medical or IVD medical device within a very short time and have your individual questions answered by our expert team.
At the Johner Institute, Claudia Schmitt supports and advises our customers in standard-compliant software development according to IEC 62304 and establishing quality management systems according to ISO 13485. As a medical informatics engineer, she has been involved in developing and approving medical devices for more than 15 years. With her experience as a quality management respresentative, she can empathize and understand where problems exist and where they can arise. With great enthusiasm and relevant experience in the areas of ISO 9001, ISO 13485, and IEC 62304, she aims to support companies in implementing their ideas and visions.
Catharina Bertram supports Johner Institute clients in placing in vitro diagnostic medical devices (IVD) on the market and is an expert in IVD performance evaluation. She is involved in the product-specific creation of technical documentation for our clients and advises on strategic product orientation. Her focus is on IVD assays and IVD software, especially AI-based software. She holds a doctorate in biochemistry and has many years of industry experience, which she brings to bear in the practical implementation of regulatory requirements. As branch and laboratory manager of a pharmaceutical start-up, she was involved in all processes related to the QM system. She was also involved in the development of various in vitro diagnostic tests.
Florian Krafft advises our clients with great commitment and enthusiasm on all aspects of medical device approval. Based in Berlin, he develops tailor-made MDR certifications for our clients. As head of our medical device team, Florian also handles project management and thus acts as an interface between the individual departments and customers on projects. Before joining the Johner Institute, he was head of a development and project management department responsible for MDR certification of non-active implants.
The conference will take place at the modern and well-equipped COURTYARD BY MARRIOTT Berlin City Center. We have reserved a block of rooms for you there. Until the end of August, single rooms are available for €149.00 per night, including breakfast, under the keyword “Medical Device Days.”
Spend a wonderful evening with us on the beach! We have made an exclusive reservation for you at Mare Beach by BeachMitte. A vacation spot in the heart of urban Berlin, it captivates with its cozy atmosphere and exudes peace and relaxation with its maritime décor and warm sand.
This unique event hall leaves nothing to be desired and is a great beach experience regardless of the weather. Look forward to excellent networking, warm sand, cool drinks, a delicious street food buffet, and guaranteed fun in the activity lounge.
Please note: Startup Day 2025 will take place as part of this year's Medical Device Days. The event will be hosted in German.
Take advantage of this opportunity to get advice on regulatory issues relating to your new medical or IVD medical device within a very short time and have your individual questions answered by our expert team.
If you have any questions about the Startup Day or the Medical Device Days, please
contact our event team directly via e-mail at [email protected].
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