Veranex Blog

4 min read

Built to Fit Your Needs: Our CDMO Capabilities

Learn about our capabilities and offerings as a CDMO We sat down with Bill Croisetiere (VP, Integrated Supply Chain), Chris Vigneau (VP, Manufacturing Solutions) to discuss our unique approach to manufacturing as a CDMO. Being both horizontally and...

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5 min read

Artificial Intelligence (AI), General Data Protection Regulation (GDPR) and Cybersecurity: 10 Misconceptions About Medical Device Software

Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers must often face a regulatory framework which does not...

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2 min read

Prioritizing Patient Safety and Fostering Innovation with the MHRAs New Roadmap for Medical Devices

On January 9, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) released a regulatory framework – Roadmap towards...

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4 min read

Strategies for Successful Clinical Data Management Rescue Studies

What is a rescue study? A rescue study is a clinical trial that is being conducted by a new vendor after having previously been conducted by another...

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2 min read

Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule

On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP)...

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2 min read

New Proposal for Extended Transition Periods for IVDs: Can Manufacturers Slow Down Transition Efforts? 

The EU Commission recently published (January 23, 2024) a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming...

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3 min read

The Role of Scientific/Medical Literature Screening and Review in Pharmacovigilance

Why search the scientific and medical literature?

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2 min read

Key Insights from NMPA Guidance Draft 01 & 02 from Our Human Factors Team

The human factors team at Veranex has reviewed the NMPA Guidance Draft 01 and Draft 02 and submitted feedback to the agency. We’re committed to...

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5 min read

Nanomaterials in Medical Devices: Biological Risks and Methodology for Biocompatibility Assessment

Introduction Nanomaterials, tiny scientific wonders that are invisible to the naked eye, hold the potential to revolutionize numerous facets of our...

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