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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 Update of Appendix 1 of the Nitrosamines Guideline

MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies

MDCG 2024-1-5: Urogynaecological Surgical Mesh Implants for Pelvic Organ Prolapse and Stress Urinary Incontinence Repair

Updated Guidance on MDR Surveillance: MDCG 2022-4, Revision 2

MDCG 2024-10: Clinical Evaluation Guidelines for Orphan Medical Devices

New MDCG Guidance Documents Released: Key Updates and Insights

New MDCG & Stakeholders Survey on MDR/IVDR Certifications and Applications Released by Notified Bodies

Latest Update on Appendix 1 of the Nitrosamine Guidelines

EU Parliament Passes Groundbreaking Proposal

New EMA Guideline on Environmental Risk Assessment for Human Medicinal Products

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Events calendar

Industry
Service

January

28.01 - 29.01

Clinical

OCT Medical Devices Europe 2025

Munich, Germany

February

02.02 - 06.02

Regulatory Affairs

Medlab Middle East 2025

Dubai, United Arab Emirates

March

11.03 - 12.03

Regulatory Affairs

RAPS Global Regulatory Strategy Conference 2025

Baltimore, Maryland, USA

May

13.05 - 16.05

Regulatory Affairs

RAPS Euro Convergence 2025

Brussels, Belgium
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