Medtech Regulatory Insights
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De-risking regulatory submissions for medical technology companies
Josh Miller, co-founder & CEO of Gradient Health focuses on the regulatory hurdles medtech companies face and the different options for overcoming these from a data perspective. Read more
29 Sep 2022
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The much-needed harmonisation between the AI Act and MDR/IVDR
Alejandro Bes, head of legal, Novartis, Francisco Javier García Pérez, counsel, Uría Menéndez look at the proposed EU AI Act. Read more
16 Sep 2022
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Is regulation killing innovation in medtech?
Dr Nicola Thorn, CEO of AND Technology Research, outlines why she feels the requirements of some regulations have brought about some insurmountable barriers for innovations, and highlights areas that can be changed. Read more
14 Sep 2022
Preparing to navigate FDA clearance to launch a new medical device
Heather Underwood, CEO of EvoEndo, talks about the lessons learned navigating through the FDA clearance process, and the preparation work that is required. Read more
7 Sep 2022
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UKCA vs CE: How new requirements changed medical device manufacturing
Ashmita Das, CEO of scientific talent platform Kolabtree, sits down with freelancers Nare Simonyan and Nida Ali to discuss how the UKCA marking has impacted medical device manufacturing in the UK. Read more
16 Aug 2022
Sponsored
Three practical steps to using AI in medical device manufacturing
Undoubtedly, there’s a lot of hype surrounding artificial intelligence (AI). It seems to be in every other headline. There’s no doubt AI has the potential to transform medical device manufacturing. Read more
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Titan Medical publishes patent application for robotic assisted surgery
Titan Medical has published international patent application which the company anticipates pursuing in the United States and other key markets under the Patent Cooperation Treaty (PCT). Read more
3 Oct 2022
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DEKRA Certification UK joins UK Approved Bodies list
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK has now joined the list of UK Approved Bodies to process medical device conformity assessments. Read more
30 Sep 2022
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BVI granted MDR certification for intraocular lens portfolio
BVI, an ophthalmic device company, has received certification for its intraocular lens (IOL) portfolio under the European Medical Device Regulation (MDR, (EU) 2017/745) from its Notified Body, the British Standards Institution (BSI). Read more
26 Sep 2022
Sponsored
Optical spine and posture analysis with uEye industrial cameras
For the diagnosis of back pain, systems for 4D measurement of body statics are very helpful. DIERS International enables high-resolution optical measurement of the human back, spine and pelvis with DIERS formetric 4D. Read more
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Unlocking the future of diabetes management
Dr Francine Kaufman, endocrinologist who has served as president of the American Diabetes Association and Senseonics chief medical officer, outlines how medtech and digital solutions can alleviate the burden of diabetes management. Read more
4 Oct 2022
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The X-factor: A smart solution for sleep apnoea
Ziv Peremen, CEO, X-trodes, explains the thinking behind the product and the trends that led them there. Read more
3 Oct 2022
Intelligent cameras in the service of health
Artificial intelligence (AI) plays a key role in the digital age. Self-learning algorithms have the potential to improve processes and be used in production, laboratory analysis and diagnostics. Read more
30 Sep 2022
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Crystal Clear: Aiding self-care and life science innovators
Ian Bolland is joined by Charlie Rapple, co-founder of Kudos, which tries to make research and information surrounding healthcare and other subjects as accessible and easy to understand as possible. Read more
23 Sep 2022
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How to create a competitive advantage in medtech during economic instability
Isabella Schmitt, MBA, RAC, director of regulatory affairs, Proxima Clinical Research and principal, M1 MedTech advises how to navigate turbulent economic times. Read more
13 Sep 2022
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De-risking regulatory submissions for medical technology companies
Josh Miller, co-founder & CEO of Gradient Health focuses on the regulatory hurdles medtech companies face and the different options for overcoming these from a data perspective. Read more
29 Sep 2022
The future of measurements in Irish medtech
Jason McGlynn, commercial manager at industrial metrology specialist The Sempre Group, shares his thoughts on measurement in Ireland’s medtech market and explains how the company’s new Dublin facility will support local manufacturers. Read more
26 Sep 2022
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Internet of Bodies: a data-led healthcare revolution
Shu Yang, senior associate and patent attorney and Sheri Jeyakumar, associate at European intellectual property firm, Withers & Rogers, comment on Internet of Bodies and the effects had on medtech. Read more
20 Sep 2022
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The much-needed harmonisation between the AI Act and MDR/IVDR
Alejandro Bes, head of legal, Novartis, Francisco Javier García Pérez, counsel, Uría Menéndez look at the proposed EU AI Act. Read more
16 Sep 2022
Shutterstock
Is regulation killing innovation in medtech?
Dr Nicola Thorn, CEO of AND Technology Research, outlines why she feels the requirements of some regulations have brought about some insurmountable barriers for innovations, and highlights areas that can be changed. Read more
14 Sep 2022
White Paper
Testing the EMR and Beyond
Discover how to deliver Exceptional Patient Care through Quality Technology in this whitepaper from Keysight Technologies Read more
Sponsored
Three practical steps to using AI in medical device manufacturing
Undoubtedly, there’s a lot of hype surrounding artificial intelligence (AI). It seems to be in every other headline. There’s no doubt AI has the potential to transform medical device manufacturing. Read more
Shutterstock
Crystal Clear: Aiding self-care and life science innovators
Ian Bolland is joined by Charlie Rapple, co-founder of Kudos, which tries to make research and information surrounding healthcare and other subjects as accessible and easy to understand as possible. Read more
Sponsored
Optical spine and posture analysis with uEye industrial cameras
For the diagnosis of back pain, systems for 4D measurement of body statics are very helpful. DIERS International enables high-resolution optical measurement of the human back, spine and pelvis with DIERS formetric 4D. Read more
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