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Tag: Medical Devices RegDesk

Cambridge Cognition Acquires eClinicalHealth, Targets Improved Virtual Clinical Trial Offerings

Cambridge Cognition Holdings PLC announced on October 12, 2022 that it acquired eClinicalHealth Ltd. (eCH) for about $1.9 million. eCH offers the Clinpal platform,...

3 Crucial Ingredients Every Life Science Case Study Needs

What separates an effective life science case study from an ineffective one? Case studies are a particularly potent part of your marketing toolkit. They’re a...

FDA Guidance on Abbreviated 510(k) Program: Overview

The article provides an overview of the regulatory policy related to the Abbreviated 510(k) Program and highlights the key points associated thereto.  ...

TGA Guidance on Clinical Evidence for Joint Prostheses: Overview

The new article describes in detail the approach to be applied for clinical evidence for joint prostheses.  Table of Contents The...

FDA Guidance on Design Considerations for Pivotal Clinical Investigations: Overview

The article provides an overview of the regulatory policy for pivotal clinical investigations in terms of design considerations.  Table of Contents ...

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