Launching an application or appliance in a highly regulated domain requires end‑to‑end traceability and unambiguous reporting of requirements
coverage, verification activities, and test outcomes across the entire development lifecycle.
Conventional process frameworks typically address these needs through prescriptive, documentation‑heavy workflows supported by complex lifecycle management platforms.
While robust, such infrastructures often introduce significant overhead: reduced engineering autonomy, constrained design
iteration cycles, steep tool onboarding curves, and substantial operational and licensing costs.
Contrary to common perception, regulatory compliance does not inherently mandate monolithic processes or rigid, sequential development models.
Modern engineering approaches—such as Agile, Scrum, or hybrid iterative‑incremental lifecycles—can be effectively applied within regulated environments
when combined with an appropriate tooling ecosystem. A carefully selected set of lightweight or commodity tools, integrated via clear traceability
schemas and well‑defined governance checkpoints, can fully satisfy regulatory obligations (e.g., requirements traceability, risk management documentation,
verification evidence capture) while enabling higher development velocity and improved team acceptance.
This lecture will include technical examples and architectural patterns derived from real projects in the medical device and
railway safety‑critical domains, illustrating how organizations can align modern engineering practices with stringent regulatory frameworks without compromising quality or compliance.
Biography
André Verschelling is Principal Consultant in Test and Trainer at ALTEN and board member of the BNTQB.
As principal consultant, he helps clients of ALTEN to setup their test strategies and processes, especially in R&D environments.
His knowledge and experiences range from large scale systems developments in highly regulated environments to small software development projects.
André is also a trainer and coach for his test colleagues and helps them grow their career in testing with both the ISTQB® curriculum and custom-made test courses.
As an ALTEN Test Ambassador he propagates the test craftsmanship at both internal and external events.
As a board member of the BNTQB, André helps to establish a body of knowledge on testing in Belgium and the Netherlands.
As webmaster he facilitates the information sharing of both the BNTQB itself as well as its partners, such as training and exam providers.
By: Andre Verschelling