Lizette de Groot

Lizette de Groot brings extensive hands-on QA/RA experience in the medical device and IVD industry. Known for her pragmatic mindset and clear communication style, she translates complex regulatory requirements into practical, actionable steps.

What makes Lizette especially valuable is her role as a freelance Lead Auditor and Technical File Reviewer for a Notified Body. This gives her direct insight into how Notified Bodies actually assess quality systems and technical documentation. She understands not only the regulations , but also how they are interpreted, reviewed, and challenged during audits. This insider perspective helps participants:
✔ Better prepare for Notified Body audits
✔ Strengthen technical documentation
✔ Avoid common compliance pitfalls
✔ Gain confidence in regulatory decision-making

Lizette’s sessions are interactive, practical, and full of real-life examples, making learning immediately applicable and impactful.

Emely Middelkoop

Emely Middelkoop is one of the driving forces behind the Quality & Regulatory Academy. With her strong background in Quality Assurance, Regulatory Affairs, and organizational development within MedTech environments, clear, pragmatic perspective on how compliance should work in practice.

She is known for her ability to translate complex regulations into practical, workable solutions and to quickly bring structure and clarity in dynamic environments. Rather than adding complexity, Emely focuses on creating approaches that are efficient, sustainable, and truly adopted by teams.

At the core of her work is the belief that QA/RA is not just about compliance, but about enabling organizations to operate safely, effectively, and with confidence. She places strong emphasis on connection and awareness, helping professionals understand not only what is required, but also why it matters, so they can take ownership in their daily work.

Through her work, Emely connects people, builds capability within organizations, and ensures that every training delivers tangible, real-world impact, both for individuals and for the organizations they are part of.

A Powerful and Complementary Partnership

Together, Emely and Lizette create a distinctive learning experience:

✔ A combination of strategic insight and hands-on, real-world expertise
✔ Practical application of regulatory requirements, not just theory
✔ Strong connection to the industry, with a focus on relevance and impact
✔ Direct insight into Notified Body expectations and audit practices

Their collaboration goes beyond training, it builds capability, confidence, and sustainable professional growth.

Why choose the Quality & Regulatory Academy?

Because learning from professionals who live and breathe QA/RA makes the difference.
Because practical experience beats theory alone.
Because confidence grows when knowledge meets passion.

With Emely Middelkoop and Lizette de Groot, the Quality & Regulatory Academy offers high-impact learning designed for today’s QA/RA professionals and tomorrow’s leaders.