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Atrial fibrillation remains a leading cause of death and disability and the most common type of arrhythmia. While radiofrequency ablation and cryoablation are two established methods of treatment, in recent years more research has been dedicated to...
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The use of artificial intelligence (AI) in clinical trials is evolving quickly. According to the research and consulting firm, Gartner, the life...
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The use of technology in clinical trials, including artificial intelligence (AI), is evolving rapidly. According to the consulting firm Gartner, “The...
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The EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the availability of...
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Our approach to Quality Management ensures that we’re always speaking the same language.
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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...
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Learn about our capabilities and offerings as a CDMO We sat down with Bill Croisetiere (VP, Integrated Supply Chain), Chris Vigneau (VP,...
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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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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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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...
