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Anyone who works in medtech product development knows that surprises are a guarantee. That’s why it’s important to create stability and predictability whenever possible — especially when it comes to a medical device supply chain. Below, experts from...
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5 min read
Atrial fibrillation remains a leading cause of death and disability and the most common type of arrhythmia. While radiofrequency ablation and...
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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...
3 min read
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...
4 min read
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
Medical Device Software (MDSW) is a growing, fast-evolving industry. However, manufacturers must often face a regulatory framework which does not...
2 min read
On January 9, the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) released a regulatory framework – Roadmap towards...
