Insights on medical device training, regulatory compliance and the future of learning in MedTech.
With more than 20 years of experience from the Medical Device and Pharmaceutical industries, Åse Ek has built her career at the intersection of product development, quality and regulatory affairs. Today, she leads the Training & Education area at GBA Key2Compliance, a role that combines deep technical expertise with a strong commitment to knowledge sharing.
From Chemistry to Regulatory Strategy
Åse is a chemist by education. Her professional journey began in product development, first in pharma and later in medtech. Early on, she realised how central regulatory understanding is to market access, not only at the time of submission, but throughout the entire product lifecycle.
“I quickly saw how much of market access is about understanding regulations and how to make use of them. That complexity fascinated me.”
Over the past ten years, training in quality and regulatory matters has been her main focus. Alongside consulting assignments, she has worked extensively as an instructor within ISO 13485, regulatory requirements, post-market surveillance and related areas.
Building on a Strong Training Heritage
Having worked as a trainer at GBA Key2Compliance for many years, Åse now carries the overall responsibility for the Training & Education area.
“It is both a responsibility and an honour to cultivate the heritage of the Key2Compliance trainings. At the same time, this field is constantly evolving. Staying ahead, both in content and format, is a key challenge.”
In close collaboration with colleagues across GBA Key2Compliance and the broader GBA Group, the ambition is to ensure that the training portfolio continues to develop in line with regulatory changes, new technologies and customer needs.
A Vision for the Future of Learning
Over the next two to three years, Åse sees professional training becoming increasingly intertwined with AI and digital platforms. New channels and formats will continue to emerge.
“Training must be accessible where people are, often in short and smart formats, while still maintaining credibility and context. The learning needs to be valid, applicable and ready to use in real-life situations.”
As part of this development, GBA Key2Compliance is also exploring new ways of delivering training through digital and scalable formats. One example is avatar-based training, where structured, high-quality content can be delivered consistently across teams, locations and languages.
“This type of format allows organisations to maintain control over both content and quality, while making training more accessible and easier to update as regulations evolve,” Åse explains.
Rather than replacing traditional training, these formats complement existing approaches and enable companies to build more flexible and future-ready training programmes.
At the same time, she emphasises that not everything should move online.
“Some learning works best live. The interaction between trainer and participants can create something unique. The kind of learning that happens in the room, in the dialogue and in the shared experience.”
The future, in her view, is hybrid. It combines digital accessibility with the depth and engagement of live interaction.
What Participants Value Most
From her experience as an instructor, participants are not only looking for regulatory knowledge. They want understanding.
“They value clarity around what the regulation actually intends to achieve. They also want to explore pragmatic and feasible solutions to their own challenges.”
Equally important is the opportunity to meet peers and exchange experiences. A well-delivered course balances preparation with flexibility. It allows space for discussion and real-life examples while ensuring structure and quality.
What Differentiates GBA Key2Compliance
GBA Key2Compliance offers a broad portfolio of courses covering the medical device product lifecycle.
Combined with long-standing experience in designing and delivering professional training, this provides a solid foundation for adapting content to specific customer needs.
The organisation’s strong regulatory and quality expertise ensures that training is not theoretical but anchored in real practice.
Training as Risk Management and Growth Enabler
Structured training is not only about competence development. It also supports better decision-making across the organisation.
A shared understanding of regulatory requirements creates alignment in how people interpret and apply them in practice. This strengthens the quality culture and makes it easier to work consistently within the quality management system.
“Employees who understand the rationale behind regulations are better equipped to act proactively. That reduces risk and strengthens long-term stability.”
One-Off Courses or Long-Term Strategy?
When asked whether training should be seen as one-off events or part of a long-term strategy, Åse’s answer is balanced.
“Sometimes a targeted course addressing a here-and-now need is exactly what a company requires. It can be a short-term investment that pays off quickly. But true competence requires a long-term strategy. A solid common base combined with regular updates as regulations evolve, supported by scalable formats that make training accessible across the organisation.”
Topics Driving Future Demand
Looking ahead, Åse expects increasing demand for training that connects the dots.
“We operate in a constant information flow. Many companies struggle to see how the different parts fit together.”
She describes it as navigating a maze. Understanding how regulatory, quality, risk management and operational processes are interconnected.
Other areas expected to grow include:
- Change management
- Supplier control and outsourcing
- Risk-based approaches and justified levels of control
A Serious Commitment to Training
For companies considering one of GBA Key2Compliance’s courses, Åse’s message is straightforward:
“We are serious about training. From preparation and content to delivery, method and follow-up. Our courses are designed to provide proven value.”
If she were to summarise the training philosophy in one sentence, it would be:
“Living our history, constantly moving forward.”
Learn more about our training programmes or explore our avatar-based training solutions.