Distinguishing Between Workshops and Training Sessions
Workshop = providing guidance and collaboratively developing the next steps.
Training = building or deepening regulatory knowledge in a targeted manner.
Strategic · Customized · Practical
Metecon Academy: Workshops and Training Courses for Regulatory Challenges
Whether it’s a strategic workshop to kick off a project or a training session designed to deepen specific knowledge, we tailor content and formats to your specific needs, your team, and your regulatory practice.
25+
Years of Regulatory Consulting Experience
50+
Experts with Hands-on Project Experience
MD · IVD · Software · AI
Broad Regulatory Expertise
Remote · On-site · at Metecon
Flexible for Your Team
Your Needs
Tackling Regulatory Challenges Together
Sometimes the goal is clear, but your team lacks the necessary expertise. Sometimes another question arises first: Where do we stand today, what actually needs to be done, and which path is the right one for us?
We develop the right format for both situations. Strategic workshops provide direction and a common foundation for moving forward. Training sessions build regulatory knowledge in a targeted manner or deepen existing expertise.
Gaining Clarity on the Current Situation
Where do we stand today? Where is action needed? Which issues must we address first? In a workshop, we’ll work with your team to map out the current situation, bring together the relevant regulatory perspectives, and lay a solid foundation for the next steps.
Build or Deepen Knowledge
New regulatory requirements, new tasks, or new employees call for targeted knowledge development. We provide your team with the expertise they need to perform their duties, tailored to their current level of knowledge, responsibilities, products, and regulatory context.
Building a Shared Understanding
Differences in knowledge, roles, and perspectives can make collaboration difficult. Workshops and training sessions help participants collectively make sense of regulatory requirements and contexts and develop a solid technical understanding within the team.
Preparing for and Supporting Change
New processes, regulatory strategies, or digital systems are transforming day-to-day work. We help teams understand the technical context, contextualize decisions, and integrate new approaches into regulatory practice.
Two formats
Workshop or training session? The goal determines the format.
Strategic Workshops
A workshop is the ideal format when the initial goal is to establish a sense of direction.
Together with your team, we assess the current situation, structure key questions and areas for action, and determine the best path forward for your company. Our experts contribute regulatory expertise and an independent outside perspective. Your team’s knowledge and experience form the foundation for our collaborative work.
Strategic workshops are therefore often the starting point for a client project. They provide clarity on what is actually needed and what the next steps might look like.
Typical goals of a workshop:
- assessing the current situation and identifying regulatory needs
- bringing together different perspectives and levels of knowledge
- making requirements, dependencies, and priorities transparent
- evaluating options for action
- developing a shared vision and approach
- establishing a solid foundation for the next project steps
Customized Training
A training session is the right format if your team needs to build or deepen its regulatory knowledge in a targeted manner.
We tailor the content and level of technical depth to the participants’ tasks, prior knowledge, and work context. It’s not just about explaining regulatory requirements. What matters most is that your team understands their significance for their own work and can apply the knowledge they’ve gained in practice.
Typical goals of a training session:
- building a foundation in regulatory knowledge
- deepening existing expertise
- understanding new or changed requirements
- preparing employees for new tasks
- standardizing knowledge within a team
- explaining regulatory concepts using concrete examples
Your Topics – Our Regulatory Expertise
The Metecon academy draws on the expertise of our various disciplines. Depending on the topic at hand, we’ll assemble the right experts for your workshop or training session.
Possible topics could include: |
|
|
|
No training catalog
Topics, content, and level of technical depth are not determined in advance. We design the workshop or training session based on your specific needs and assemble the appropriate Metecon experts for the task.
"The workshop with Metecon was incredibly valuable for us. We found it particularly helpful that Metecon examined our processes using concrete examples and provided feedback that we could implement right away. Time literally flew by, and we felt that Metecon tailored its approach specifically to our situation. We’re taking away many ideas and clear insights that will help us approach the next optimization steps in a structured way."
Dr. Katrin de RueHead of QM & Regulatory Affairs • GFE Blut
From the Research Question to the Format
Here's how to find the right format for your team
1
Clarify the Goal and Key Questions
What should your team know, understand, or have worked out together after the workshop or training session?
We clarify the current situation, objectives, target audience, and existing knowledge.
2
Developing the Format and Content
Based on this, we assemble the appropriate experts and develop the agenda, key topics, and working methods.
Your project brief determines the content.
3
Working Together or Deepening Knowledge
The workshop focuses on jointly assessing the current situation and developing a plan for moving forward.
In the training session, we focus on targeted knowledge building, in-depth technical expertise, and applying this knowledge to your employees’ day-to-day work.
4
Putting Results into Practice
What matters most is what continues to have an impact within the company after the workshop or training session.
The insights gained and the knowledge acquired lay the foundation for decisions, next steps, new ways of working, or a follow-up project.
The key is the transfer
For us, a workshop or training session is successful when the insights and knowledge gained continue to have an impact in your day-to-day work: in your decisions, processes, projects, and in how your team works together.
Remote or on-site? We're flexible in how we conduct our work.
Workshops and training sessions can take place remotely, at your location, or at Metecon’s offices. The most suitable setting depends on the objectives, the group of participants, and the desired approach.
An on-site workshop can be useful for intensive teamwork. Remote sessions are often a good fit for knowledge transfer, distributed teams, or compact formats. Together, we’ll choose the option that best supports the goal of the session.
Metecon Expertise
Practical Regulatory Knowledge
Our experts do more than just explain regulatory requirements. They work on these issues every day alongside manufacturers of medical devices and in-vitro diagnostic medical devices.
As a result, our workshops and training sessions combine regulatory expertise with project experience, concrete use cases, and an understanding of the interconnections between different disciplines.
This creates knowledge that helps your team contextualize regulatory requirements and make informed decisions within their own work context.
"Especially when dealing with complex regulatory or organizational issues, the first step should be to establish a shared understanding of the initial situation. Our workshops provide guidance in this regard. Our training sessions ensure that this knowledge is embedded within the team."
Katharina ThievessenManaging Director • Metecon GmbH
Frequently Asked Questions About the Metecon Academy
What workshops and training courses does the Metecon Academy offer?
The Metecon Academy offers customized workshops and training sessions on regulatory issues in the medtech industry. The content is specifically tailored to manufacturers of medical devices and in-vitro diagnostic medical devices and can cover topics such as regulatory affairs, quality management, clinical affairs, post-market activities, software, cybersecurity, AI regulation, or regulatory digitization.
There is no fixed training catalog. The topic, level of technical detail, and format are tailored to your specific questions and your team’s needs.
What is the difference between a workshop and a training session?
A strategic workshop is ideal when the goal is to first establish a clear direction and jointly develop a course of action. The focus is on the current situation, regulatory areas of focus in the medtech sector, priorities, and possible next steps.
A training session is designed to build specific knowledge or deepen existing knowledge on a particular regulatory topic. The content and level of technical detail are tailored to the participants’ current level of knowledge and their specific responsibilities.
When is a strategic workshop a good idea?
A strategic workshop is useful when a regulatory issue has not yet been fully resolved, when different perspectives within the team need to be reconciled, or when the goal is to first gain clarity on the need for action and priorities.
For medtech companies, such workshops often mark the beginning of a project. They help the client team assess their current situation and jointly develop a solid foundation for moving forward.
Who are the Metecon Academy's workshops and training courses intended for?
These programs are designed for manufacturers of medical devices and in-vitro diagnostic medical devices, as well as their technical, project, and management teams.
Depending on the topic, participants may include, for example, employees from regulatory affairs, quality management, clinical affairs, development, software, most-market surveillance, or related functions. The content is tailored to the roles, responsibilities, and knowledge level of the respective target audience.
Is it also possible to include company- or product-specific content?
Absolutely. Workshops and training sessions are specifically tailored to your company’s products, IVDs, medical device software, processes, documents, roles, or regulatory issues.
It is precisely this connection between regulatory requirements and the specific work context that helps teams not only understand the theory but also apply it to their own practice.
On which regulatory topics are workshops and training sessions available?
Possible topics range from regulatory strategy and market access to quality management, technical documentation, risk management, verification and validation, and biosafety, as well as clinical affairs, PMS, PMCF/PMPF, vigilance, and CAPA.
Medical device software, cybersecurity, AI regulation, regulatory digitization, and international approval can also be the subject of a workshop or training session—provided they align with your specific needs. Your specific requirements are always the deciding factor.
Can a strategic workshop lead to a subsequent consulting project?
Yes. Strategic workshops often mark the beginning of a client project because they help clarify the initial situation, regulatory requirements, and priorities collaboratively.
If this reveals a need for further support, Metecon can assist with the next steps as part of a consulting or implementation project. However, participating in a workshop does not obligate you to a follow-up project.
What is the process for planning a workshop or training session?
To begin with, we clarify your specific questions, objectives, target audience, and existing knowledge.
We then assemble the appropriate Metecon experts and develop the agenda, content, level of technical depth, and methodology. This results in a format tailored to your company, your team, and your regulatory situation.
What sets the Metecon academy apart from standardized continuing education programs?
The Metecon academy does not use pre-packaged course programs. Workshops and training sessions are tailored to each client’s specific regulatory challenges.
In doing so, we draw on the practical experience our experts have gained from client projects involving medical devices, IVDs, and regulatory processes. The goal is not merely to impart knowledge, but to foster an understanding that can be applied in day-to-day work.
How do I request a workshop or training session from Metecon?
Please send us your inquiry and, if already known, information regarding the topic, objective, target audience, and desired timeframe.
In an initial discussion, we’ll work together to determine whether a strategic workshop, a training session, or another approach makes the most sense for your needs.
Tackling Regulatory Challenges Together
Talk to us about your specific needs. Together, we’ll determine whether a strategic workshop or customized training is the right starting point for your team, and we’ll develop content and a format tailored to your needs.
Your contact person:
Dr. Caroline Arnold
Head of Sales
T: +49 621 123469-037
caroline.arnold@metecon.de
