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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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

New MDCG 2020-16 Revision 3 Guidance Documents Released

MDCG 2022-3 Rev.1 released

Revision of MDCG 2019-13 released

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Events calendar

Industry
Service

November

17.11 - 20.11

Medical Devices

Medica 2025

Düsseldorf, Germany

December

11.12 - 11.12

Medical Devices
Pharma & Biotech

Dutch Life Science conference

Leiden, The Netherlands
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