Biocompatibility

What’s Biocompatibility?

By Marina Daineko

…Biological Evaluation documented in the BER can’t guarantee freedom from potential biological hazards. When you or I use a medical device, unexpected adverse reactions might occur…We’re complex beings! That’s why…

…Biological Evaluation documented in the BER can’t guarantee freedom from potential biological hazards. When you or I use a medical device, unexpected adverse reactions might occur…We’re complex beings! That’s why…

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Biocompatibility Testing and Fraudulent Data in the Age of AI

By Michelle Lott

…to the FDA. I know of four completely unrelated companies who unknowingly used the same testing lab, submitting similar data to the FDA – all pulled from 510(k) submissions approved…

…to the FDA. I know of four completely unrelated companies who unknowingly used the same testing lab, submitting similar data to the FDA – all pulled from 510(k) submissions approved…

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MTI Newswire

ThisWeek in MedTech – August 23, 2024

company said. Read the story > MedtechDive 8/13 Medtronic wins FDA approval for asleep deep brain stimulation Medtronic said Monday it is the first company to receive FDA approval to…

company said. Read the story > MedtechDive 8/13 Medtronic wins FDA approval for asleep deep brain stimulation Medtronic said Monday it is the first company to receive FDA approval to…

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Clinical Trials

Transitioning EU Clinical Trials: Key Steps for Compliance by 2025

By Diede van Bladel

…information on clinical trials. This revision was the result of feedback provided by users of the CTIS portal (including sponsors, clinical research organizations, academia, national competent authorities, ethics committees, health…

…information on clinical trials. This revision was the result of feedback provided by users of the CTIS portal (including sponsors, clinical research organizations, academia, national competent authorities, ethics committees, health…

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logistics

Transform Medical Device Logistics With Smart Packaging Strategies

By Emily Newton

…extremely costly, especially given the price and necessity of many health care products. One example comes from two companies collaborating to bring 5G network connectivity and Internet of Things tech…

…extremely costly, especially given the price and necessity of many health care products. One example comes from two companies collaborating to bring 5G network connectivity and Internet of Things tech…

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medical device scrutiny

Soaring Medical Device Scrutiny: How is the Market Adapting?

By Mike Baird, Peter Muller

Fortune Business Insights, June 17, 2024: https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085 [2] The independent Census-wide survey, commissioned by Schlafender Hase, was conducted in late May/early June 2024, among 202 regulatory professionals at Class 2…

Fortune Business Insights, June 17, 2024: https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085 [2] The independent Census-wide survey, commissioned by Schlafender Hase, was conducted in late May/early June 2024, among 202 regulatory professionals at Class 2…

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