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References: Medical Devices

We are an experienced provider of regulatory affairs and CRO services. 

References: Medical Devices

We are an experienced provider of regulatory affairs and CRO services.

Medical device & IVD manufacturers

Select Medical Devices references 

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Reference stories: What do our customers say about us?

Computer Game as a Medical Device: A Clinical Study of Peili Vision’s EFSim Test Software

peili-vision-logoPeili Vision’s software aims to expedite the identification of challenges in children's executive function and potential ADHD issues in healthcare and at school. The collaboration of Peili Vision and Labquality started already in 2021, and more recently, Peili Vision has chosen Labquality as the partner for a clinical study to assess the performance and safety of their browser-based, game-like medical software.

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Labquality Supports Biomendex in CE Marking Journey for Adaptos® Ortho Wedge Bone Graft Substitute

Biomendex_logo_BlackBiomendex has chosen Labquality as their CRO partner for their randomized, controlled, multi-center clinical investigation to evaluate Adaptos® Ortho Wedge Bone Graft Substitute. The development of a high-risk class implantable medical device within a heavily regulated environment inevitably presents challenges for the project.

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Meeri Säily

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Meeri Säily
Sales Director, Consulting and Clinical Trials
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meeri.saily@labquality.com

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The solid know-how and experience of Labquality’s experts bring clarity to device requirements and regulations.

Technical documentation

Technical documentation

We can support you in getting your Quality Management System and Technical Documentation compliant with the regulations.

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Regulatory Life cycle

Regulatory Life cycle

We help medical device companies in meeting the new, comprehensive requirements and compliance expectations during the entire lifecycle of their products.

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Clinical Investigation

Labquality provides services and expertise in the planning, preparation, and conduct of clinical investigations.

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Regulatory Essentials in Health Tech

Regulatory Essentials in Health Tech

This training series provides an efficient introduction to the regulatory essentials to turn regulatory compliance into business advantage.

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