Events

Management review in MedTech: Why it makes sense to have a closer look

31.01.2025 – 10 AM | Online

The management review is one of the central topics of ISO 13485 (also 9001 and others). After all, it is about the review and outlook of product quality. If you do it right, it is a powerful tool for planning the next steps and THE element for initiating and actively managing continuous improvement.
Unfortunately, I repeatedly had to conduct management reviews that have not produced good results.

It’s no wonder that this area is always conspicuous in internal and external audits and leads to deviations. It is relatively simple if you follow a few rules.
I will show you the most effective ones in this live webinar! NOTE: we will have a short Q&A session in the end so feel free to bring your questions!

Q&A session for MedTech Professionals

07.02.2025 – 10 AM | Online

• Do you have acute questions or complex problems in the areas of 13485, 14971, MDR, FDA 8.20 or MDSAP?
• Perhaps you have not yet asked because there were obstacles? I know this, because I have sometimes spent years looking for answers to issues that were simply not clear to me. I always wished for a forum where I could ask these questions in an uncomplicated way and then get well-founded answers. But that doesn’t exist.
• This Q&A session is therefore aimed at all professionals in the field of quality/regulatory in MedTech companies and those who are very interested in these topics.

Rules:

• You can ask your questions unannounced in real time and you can describe the context in such a way that there is no reference to your job or your company.
• There will be no publication, your questions will not be processed in any other way and we undertake to maintain confidentiality about all questions.
• Ask your question(s) as precisely as possible, because as you know: a good description of the problem often contains a clue to the solution.

Promise:

• You will receive practical answers – from experts who have many years of experience in the MedTech sector and are very familiar with the standards, regulations and laws.
• If your question is so complex that it cannot be answered in the Q&A session, we guarantee an answer in the follow-up.

The 5 secrets of a successful project kick-off

14.02.2025 – 10 AM | Online

Do you know that too?

• At the end of the project, lots of new people are thrown into the project so that the deadline can be met
• Responsibilities are shifted back and forth during the project phase because nobody really feels responsible
• Things that should actually be clear are up for discussion every day
• Little things that need to be done always take more time than necessary
• The project manager seems overwhelmed, somehow incompetent and it looks as if he is tilting at windmills
• Hectic reworking is required because it “suddenly” becomes apparent that fundamental things have not been completed

How to get projects on track better? I’ll show you in this live webinar!
NOTE: Finally, we will hold a short Q&A session where you can ask both existing questions and questions that arise during the webinar!

Q&A session for MedTech Professionals

07.03.2025 – 10 AM | Online

• Do you have acute questions or complex problems in the areas of 13485, 14971, MDR, FDA 8.20 or MDSAP?
• Perhaps you have not yet asked because there were obstacles? I know this, because I have sometimes spent years looking for answers to issues that were simply not clear to me. I always wished for a forum where I could ask these questions in an uncomplicated way and then get well-founded answers. But that doesn’t exist.
• This Q&A session is therefore aimed at all professionals in the field of quality/regulatory in MedTech companies and those who are very interested in these topics.

Rules:

• You can ask your questions unannounced in real time and you can describe the context in such a way that there is no reference to your job or your company.
• There will be no publication, your questions will not be processed in any other way and we undertake to maintain confidentiality about all questions.
• Ask your question(s) as precisely as possible, because as you know: a good description of the problem often contains a clue to the solution.

Promise:

• You will receive practical answers – from experts who have many years of experience in the MedTech sector and are very familiar with the standards, regulations and laws.
• If your question is so complex that it cannot be answered in the Q&A session, we guarantee an answer in the follow-up.

No decision is also no solution

14.03.2025 – 10 AM | Online

Six reasons not to make decisions:

1. I don’t have all the facts, I need more information first
2. I don’t know how to decide
3. Distractions!
4. No capacity
5. No “time”
6. Implementation contradicts my values, I’m afraid of the consequences

How to make more meaningful decisions faster? I’ll show you in this live webinar! NOTE: Finally, we will hold a short Q&A session where you can ask existing questions as well as questions that arise during the webinar!

How to keep a quality management system compliant

20.03.2025 – 10 AM | Online

If you look at the results of external or internal audits, there are always similar findings. These are things that have been known for a long time. They are not properly processed, executed or documented.
Because they are either too complicated to describe, are not effective in their execution or are simply inefficient.

Standards and regulations tell us what we should pay particular attention to. The interpretation of these and their implementation in the QMS as well as in daily life are the key to keeping the system compliant.
How does that work? I will show you in this webinar.

Risk Management / Change Management in MedTech

28.03.2025 – 10 AM | Online

Risk management in MedTech is one of the central topics that is repeatedly reviewed by external auditors. And rightly so, as there are always gaps in the documentation and assessment. The EU MDR has once again sharpened the focus of the complex in order to clarify points of discussion from the past.
Let’s be honest: in the interests of the patient, this is certainly the right thing to do.

And then there is change management, which makes it even more complex.
The healthy balance between pragmatism (finding a quick response to change requests) and administration (correct documentation of the changes) is always a test in organizations.

In this webinar, I will show you the secrets of how to set up risk management and change management in such a way that they can be used efficiently as a method.