Pieter Smits

Project Manager at QbD Group

Pieter is a Project Manager at QbD Group, coordinating multi-disciplinary teams to deliver quality and regulatory consulting projects.

9 articles

Software Solutions & Services13 may 2026 7 min

How MedTech's AI Playbook Can Accelerate Compliant AI Adoption in Pharma

Discover how MedTech's validated AI approach can help pharma accelerate compliant AI adoption across R&D, clinical trials, and GMP operations.

Software Solutions & Services13 may 2026 4 min

Why AI Is Too Generic for Regulatory Conversations in Life Sciences

Discover why AI governance in life sciences depends on intended use, risk context, and control frameworks rather than the AI label itself.

Software & Digital Health29 abr 2026 3 min

What Pharma Can Learn from MedTech's AI Validation Playbook

Pharma is still figuring out AI validation. MedTech already solved it. Learn what to copy from MedTech's proven playbook to ensure GxP compliance and real-world impact.

19 mar 2026 3 min

AI in Life Sciences

Leveraging AI in life sciences is powerful, but also complex under GxP. In this joint webinar, QbD Group and delaware show how to implement AI in a trustworthy, validated, and inspection-ready way, with the right approach to data, explainability, and lifecycle management.

Software Solutions & Services25 sept 2025 3 min

MDR & Cybersecurity: What Your Technical File Needs to Prove

Cybersecurity is a key MDR requirement. Discover what your technical file must include to meet EU cybersecurity expectations for medical devices.

Software Solutions & Services16 jul 2025 6 min

MDSW for Startups: A Practical Guide to Compliant Medical Software Development

Startups, master compliant medical device software (MDSW) development. This guide covers IEC 62304, Risk Management, AI Act, and Notified Body expectations for market entry.

Software Solutions & Services25 mar 2024 3 min

Impact of the AI Act on the MedTech and Life Sciences Industry

Explore how the AI Act impacts MedTech and Life Sciences, and how QbD Group can guide you through its complexities. Contact us to learn more.

Qualification & Validation28 sept 2023 1 min

Navigating Project Complexities: QbD's Project Management Process for Qualification and Validation Projects

Qualification and validation projects play a pivotal role in guaranteeing that pharmaceuticals, medical devices, and ATMPs meet stringent regulatory requirements.

Software Solutions & Services26 jul 2022 9 min

AI and machine learning validation: strategies and examples

Need insight into the right validation strategy for your AI- or ML-based systems and products? Learn more here!

Usamos cookies para mejorar tu experiencia

Usamos cookies esenciales para el funcionamiento del sitio y cookies de análisis opcionales para mejorar nuestros servicios. Consulta nuestra Política de privacidad y Política de cookies.