• There are no suggestions because the search field is empty.

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

New MDCG Guidance on Safety Reporting for Performance Studies of In Vitro Diagnostic Medical Devices under EU Regulation 2017/746 Released

New MDCG Guidance on Investigator’s Brochure Content for Clinical Investigations of Medical Devices

New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies

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 the Development and Assessment of Medicinal Products Involving Companion Diagnostics (CDx)w EMA FAQ on medicinal products development and assessment involving a CDx

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

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
Load More
circle-box circle-box-mob