Building a Quality Performance Evaluation Report (PER) as per Regulation (EU) IVDR 2017/746

Building a Quality Performance Evaluation Report (PER) as per Regulation (EU) IVDR 2017/746

Building a Quality Performance Evaluation Report (PER) as per Regulation (EU) IVDR 2017/746


The European Unionโ€™s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is significantly affecting the IVD industry and companies selling into the EU market as they get ready to meet tougher medical device compliance requirements.

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South Carolina, USA:

PO Box 61, Fair Play, South Carolina, 29643

Delaware, USA:

16192 Coastal Highway, Lewes, Delaware, 19958

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SARACA is a rapidly growing product engineering services company with deep expertise in digital, artificial intelligence, and emerging new technologies. Founded in 2014, SARACA is powered by Gen Z and Millennials with greater focus on agility, customer centricity, faster technology adoption, and adherence to cultural sensitivity. Our digital natives perform their actions with speed and ensure that we exceed customer expectation every single time. SARACA adopted vertically integrated approach to build depth in the industries we operate in. Over the years we have built strong expertise in aerospace, defense, space, automotive, medical devices, Industrial, Farm Equipment, rail transportation, technology, semiconductor, and many other industries.

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