Medtech Regulatory News
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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
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FDA grants approval for brain stimulation technology for depression
Magnus Medical, a medical device company and developer of brain stimulation technology for treatment of neuropsychiatric disorders, has received 510(k) clearance from the FDA for the SAINT Neuromodulation System for MDD in adults. Read more
13 Sep 2022
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SyncThink's EYE-SYNC receives CE mark
SyncThink, a neurotechnology company, and makers of the EYE-SYNC technology, has completed CE Mark certification, affirming conformity to European Medical Device Regulation (MDR). EYE-SYNC will be registered as a Class I medical device. Read more
11 Aug 2022
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BioCircuit receives FDA clearance for nerve repair device
BioCircuit Technologies, a National Institutes of Health (NIH)-funded medical device company focused on tissue repair and neuromodulation, has received FDA 510(k) clearance for its nerve repair device, Nerve Tape. Read more
22 Jul 2022
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Greenlight Guru receives ISO 9001 and 27001 certification
Greenlight Guru, developer of the MedTech Lifecycle Excellence Platform, is now certified by the International Standards Organisation for both ISO 9001 and ISO 27001. Read more
21 Jul 2022
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MedTech Europe survey shows certification timescales at all-time high
MedTech Europe has published a report following a survey of its members to analyse the availability of medical devices in 2022 in connection to the implementation of the new EU Medical Device Regulation (MDR). Read more
18 Jul 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
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How prepared is your business for the new EU MDR and IVDR regulations?
The year 2017 saw the introduction of two regulations in Europe - the new Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). Read more
30 Aug 2022
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Intertronics launches new series of wearables adhesives
To help manufacturers of wearable devices adapt to industry trends and customer requirements, adhesives and dispensing equipment specialist Intertronics has introduced the Dymax 2000-MW series of medical wearables adhesives and encapsulants. Read more
1 Jul 2022
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Skin patch for vaccine delivery receives further Australian government backing
Vaxxas will receive an AU$8.2 million grant as part of the Australian Federal Government’s MMI to support the manufacturing scale-up of its technology that allows vaccines to be applied to the skin using a small patch. Read more
28 Sep 2022
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SyncThink rebrands as NeuroSync in bid for market growth
Neurotechnology company SyncThink will rebrand the company as NeuroSync, as it looks to grow its stance in the neurological health market. Read more
27 Sep 2022
Breath diagnostic specialist Avelo closes CHF 2.2m round
Avelo, a breath diagnostics company with a mission to make every breath count for better infectious disease diagnosis, has closed a CHF 2.2 million seed round. Read more
27 Sep 2022
Johnson & Johnson Vision Care Ireland expands Limerick facility
Johnson & Johnson Vision Care Ireland, eye health specialist and part of Johnson & Johnson MedTech, has expanded of its existing facility in Plassey, Limerick. Read more
26 Sep 2022
Polyrack highlights cross-technology partner capabilities
The Polyrack Tech-Group is highlighting itself as a cross-technology partner for individual case and systems solutions for a wide range of quantities. Read more
26 Sep 2022
Parenteral drug autoinjector testing – higher throughput and less risk
ZwickRoell examines why autoinjector testing after the final fill and finish can be so challenging. Read more
28 Sep 2022
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Seeing the light: New applications for light curable adhesives in medtech
Peter Swanson, managing director of adhesives specialist Intertronics, discusses some of the latest formulations of UV curing adhesives used for assembling wearable medical devices. Read more
27 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
GMP Annex 1 - The impact on air monitoring programs
After the latest revision to EU GMP Annex 1 in 2022, Eric Clement Arakel and Myriam Gueye at Sartorius explain the effect the newest form of the guidance has on both medical device and pharmaceutical manufacturers. Read more
21 Sep 2022
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Battling microbial contamination
Elaine Gemmell, head of regulatory affairs, InnoScot Health, writes about the need to implement comprehensive measures with increasing prevalence of microbial contamination. Read more
28 Sep 2022
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Will life sciences now get strong and stable government?
Ian Bolland comments on the recent changes in government in the UK. Read more
23 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
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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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Avoid false positive results in endotoxin testing
Endotoxins can be a risk to patient safety. Even a low endotoxin concentration in the blood stream can produce inflammation in the human body. endotoxins, frequent and reliable testing for endotoxin levels on medical devices is required. Read more
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Intertronics launches new series of wearables adhesives
To help manufacturers of wearable devices adapt to industry trends and customer requirements, adhesives and dispensing equipment specialist Intertronics has introduced the Dymax 2000-MW series of medical wearables adhesives and encapsulants. Read more
1 Jul 2022
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
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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