Verdict Medical Devices

News, views and contacts from the global Verdict industry
20 July 2018
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Greiner Bio-One Preanalytics

White Papers

Part II: US FDA Quality System Regulation Vs ISO 13485:2016
This tool clarifies the corresponding relationships between the ISO 13485:2016 (medical devices, quality management systems) requirements for regulatory purposes clauses and the US Food and Drug Administration (FDA) quality system regulation.

Designed for the User
Medical device design is commonly influenced more by aesthetics and engineering principles than basic usability. Founder and president of Erdmann Design Raimund Erdmann highlights how his design consulting firm is transforming the way manufacturers conceive end-user requirements.

Part I: US FDA Quality System Regulation Vs ISO 13485:2016
This white paper features an alignment chart that can be used to clarify the corresponding relationships between the US Food and Drug Administration (FDA) 21 CFR 820 and ISO 13485:2016 regulatory guidelines.

anteris – Let’s Connect

Ionisos Facility List
Ionisos is your partner in sterilisation by ionising rays (gamma and e-beam) and ethylene oxide.

Press Releases

Incident Management and Human Error Prevention Workshops
NSF International has announced up-coming workshops in September, including topics such as incident management and human error prevention.

Ginolis to Showcase Automated Optical Inspection System at the AACC Clinical Lab Expo
Ginolis has announced it will be introducing the Ginolis Pixie at the AACC Clinical Lab Expo in Chicago, US.

Summarising the IVDR Challenge
The new in-vitro diagnostic regulation (IVDR) entered into force on 26 May 2017. As the date of application for the IVDR is 26 May 2022, 20% of the transitional period of five years has already passed. This is a good opportunity to summarise the current situation.

Happy Birthday MDR
The Medical Device Regulation (MDR) entered into force on May 26th 2017. Since then, it has been the focus of almost all relevant medical device conferences and training institutions, including LinkedIn groups, webinars and internet blogs.

A Comprehensive Overview of Design Verification
The US Food and Drug Administration (FDA) and the international regulatory standards continue to evolve and become more stringent. Medical devices are also becoming smaller and more complex in design and their functionality. This makes the process of design verification even more important, not only to comply with regulations but also to design the highest-quality part and production process.


Neuromodulation: where to invest next?
For an investor, neuromodulation is a double-edged sword. Although it is one of the fastest growing medical device markets in the healthcare industry, it involves a mechanism of action that is not fully understood. As a result, the market hinges on a few experimental results that could halt the industry.

Researchers create technique for personalised bone grafts
Scientists from the New York Stem Cell Foundation (NYSCF) Research Institute have developed a new bone engineering technique called segmental additive tissue engineering (SATE), which enables the combination of segments of bone engineered from stem cells to create large-scale, personalised grafts.

AI accurately predicts genetic mutation effects in genome dark matter
US-based scientists at the Flatiron Institute's Center for Computational Biology (CCB) and Princeton University have created a machine learning framework, called ExPecto, which can predict the effects of mutations in the ‘dark matter’ regions of the human genome and could one day aid in drug therapy selection.

Tech watch: machine learning in healthcare
From modeling disease risk to helping with diagnosis, artificial intelligence is starting to make itself felt in the medical field. Abi Millar looks at the latest studies and technological developments.

Dubai Chamber pilots AXA’s 360 Doctor Check-up Station
The Dubai Chamber of Commerce and Industry has piloted a trial of the new AXA 360 Doctor Check-up Station, a device that uses advanced technology to provide preventive healthcare to users.


The Double Coating that Spares Everything Except Fungi
Fungal attacks on elastic polymer materials in the body, such as silicone and polyurethane, are a serious problem.

Standardising USB in Medical Devices
USB is gaining popularity in the medical segment. One of the major challenges for medical designers is medical standards

Connecting Healthcare with USB Devices Project
Telehealth systems enable the healthcare industry to cope with an ever-increasing elderly population and the associated chronic diseases.

The Perfect Cure: IR Spot Curing Speeds Production and Saves Energy
Abstract: A new generation of advanced infrared spot curing systems delivers optimal curing quality, cuts cure time four

Medical Surgical Instrument MLE and Plasma Surgical – Developing the PlasmaJet®
"MLE possess a remarkable technical ability; they are brilliant at understanding a brief and are very passionate and sin

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