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

Why-self-inspections-or-internal-audits-are-essential-for-your-QMS-1536x864
Circles_banner_news&events

Select your

or

Select your

Industry

or

Service

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

Recent Posts

New Team-NB Position Paper Released on IVDR certification process

New Revision to MDCG 2020-16 Guidenance Document Released

Fifth revision to MDCG 2019-6 Guidance document released

Call for expression of interest in coordinated assessment of clinical investigations/performance studies

PMS Statutory Instrument + MHRA Guidance released (Great Britain)

New MDCG Guidance documents released

Expert Panel Advice on SARS-CoV-2

New revision to EMA Guidance documents released

New revisions of the Preliminary Assessment Review templates, forms and annexes

Second revision to MDCG 2023-3 Guidance document released

data-not-found No Items Found! Please Try Some Different Keywords
circle news

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
Load More
circle-box circle-box-mob

Upcoming webinars

webinar-image

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
Read more