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Successful ISO 17025 accreditation assessment at IMT Analytics Inc.
On 14 and 15 March, the ISO 17025 accreditation assessment for the U.S. calibration laboratory took place at IMT Analytics Inc. in St. Petersburg FL. IMT Analytics Inc. passed with „zero findings“. This result means that we should have our accreditation in about 4 to 6 weeks and will be able to offer ISO 17025 […]
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5 Years of Device Development under the MDR – Lessons Learned
Author/Source: Rutger Flink, CEO / Founder at PulmoTech BV Over the last 5 years, PulmoTech has developed a Class IIb device under the Medical Device Regulation (MDR). Following our certification, I wanted to share some (hard) lessons learned. Developing a device as a startup is difficult enough, and I wanted to know some of these […]
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Effects of Europe’s AI Act on the Medical Device Industry
The European Union (EU) has taken steps to regulate artificial intelligence (AI) within medical devices. The EU Artificial Intelligence Act (AI Act), applies to various industries, including medical device manufacturers. The AI Act introduces a new set of requirements for AI systems, which will complement the existing regulations such as the EU Medical Device Regulation […]