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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New MDCG Guidance on Updating the European Medical Device Nomenclature (EMDN)

New MDCG Guidance Released: Device-Specific Vigilance Document

Newly Published Harmonized Standards for MDR and IVDR Compliance

EU Council Endorses Proposal to Amend IVDR and MDR Regulations

Proposed Amendments to IVDR and MDR: Transitional Provisions, EUDAMED Roll-Out, and Supply Chain Interruptions

Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers

New EMA FAQ on medicinal products development and assessment involving a CDx

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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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