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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 safe devices that are essential for healthcare systems. The amending regulation extends the...
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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...
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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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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...
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