3 min read
Five Advantages of Veranex’s Quality Management Systems
Our approach to Quality Management ensures that we’re always speaking the same language.
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4 min read
2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European...
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,...
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...
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...
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...
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)...
2 min read
New Proposal for Extended Transition Periods for IVDs: Can Manufacturers Slow Down Transition Efforts?
On 23 January 2024, the EU Commission published a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to...
3 min read
The Role of Scientific/Medical Literature Screening and Review in Pharmacovigilance
Why search the scientific and medical literature?