Product Development Lifecycle

RECENT BLOGS

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  Artificial Intelligence in Clinical Studies

  Artificial Intelligence (AI) is a growing field of interest for many industries, including those of medical devices...

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  Selecting the Right Electronic Data Capture (EDC)

  What is EDC? EDC stands for electronic data capture. This usually refers to the processes of an...

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  Phases and Stages of Clinical Trials

  Clinical research for pharmaceuticals and devices follows the same general path. The first trial is a small...

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  Decentralized Clinical Trials

  Decentralized clinical trials (DCTs) are becoming increasingly popular, with the increased use of electronic systems and novel...

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  The Value of a Clinical Events Committee (CEC)

  What is a CEC? In clinical trials that include a high-risk patient demographic, a clinical events committee...

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  The Power of Post-Market Clinical Data

  For medical devices, ensuring safety and efficacy doesn’t stop once a product hits the market. Post-market clinical...

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  EU MDR Article 61 Clinical Evaluation

  The European Union (EU) Medical Device Regulation 2017/745 (EU MDR) aims to ensure a high level of...

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  Challenges of Demonstrating Biological Equivalence per ISO 10993-18 and EU MDR

  In the European Union (EU), a device is considered equivalent if it fulfills all the requirements of...

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  Regulatory Challenges for Novel Implantable Devices under EU MDR

  In the European Union (EU), the Medical Device Regulation (EU MDR) has replaced the Medical Device Directive...

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