Regulatory Updates

The QbD Group regulatory updates blog provides professionals in the life sciences with timely and insightful information on the latest regulatory trends, guidelines, and compliance requirements. Covering topics from pharmaceutical manufacturing standards to medical device approvals, the blog aims to support readers in navigating complex regulatory landscapes, ensuring product safety, and accelerating time to market. Whether you're involved in quality assurance, regulatory affairs, or product development, this blog offers valuable resources to keep you informed and compliant.

Regulatory Updates

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Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD

Recent Posts

New MDCG 2020-16 Revision 3 Guidance Documents Released

MDCG 2022-3 Rev.1 released

Revision of MDCG 2019-13 released

New MDCG 2024-16 form released

New MDCG Guidance document released on the implementation of the Master UDI-DI solution for contact lenses

New MDCG Guidance document released

New Q&A released on the gradual roll-out of EUDAMED

MDCG 2023-3 Rev 1 released

First Revision of MDCG 2021-25 Released

MDCG 2024-12 released

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Events calendar

Industry
Service

November

17.11 - 20.11

Medical Devices

Medica 2025

Düsseldorf, Germany

17.11 - 20.11

Pharma & Biotech
Medical Devices

Medica

Dusseldorf, Germany

December

11.12 - 11.12

Medical Devices
Pharma & Biotech

Dutch Life Science conference

Leiden, The Netherlands
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Upcoming webinars

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Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs

This live webinar will provide clear, experience-based guidance on how to manage pharmacovigilance (PV) across Europe without overextending your resources. You’ll learn how to balance global consistency with country-specific requirements, meet strict European timelines with lean teams, and apply practical, proven strategies that strengthen both central oversight and local execution.
Vigilance
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