Medtech, innovation

Wearables Revolutionize Classic Medicine

By Dr. Lutz Retzlaff

…solutions for monitoring many types of complaints at home or in clinics. Start-up company Biovotion has created an arm cuff that continuously captures medically relevant data that is available to…

…solutions for monitoring many types of complaints at home or in clinics. Start-up company Biovotion has created an arm cuff that continuously captures medically relevant data that is available to…

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Checkbox

The Ultimate QA/RA Cheat Sheet

By Thomas Maeder

…information on all aspect of FDA regulation of devices. Several years ago MedTech Intelligence compiled a basic list of non-commercial regulatory reference links, most from the FDA itself, which were…

…information on all aspect of FDA regulation of devices. Several years ago MedTech Intelligence compiled a basic list of non-commercial regulatory reference links, most from the FDA itself, which were…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Is Your Cleanroom Clean? Prove it!

By Dr. Christopher Joseph Devine

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 06, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm…

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2017, September). FDA.gov Website. Retrieved October 06, 2017, From https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm…

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Grant Geiger
Soapbox

Hospital of the Future: Unlock the Key to Patient Happiness

By Grant Geiger

It is no secret that each year hospitals and healthcare companies are being asked to do more with less. This leaves most industry executives looking towards technology advancements for the…

It is no secret that each year hospitals and healthcare companies are being asked to do more with less. This leaves most industry executives looking towards technology advancements for the…

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Ameing for Asia

Asiaā€™s Neurology Market

By Ames Gross

…undergo rapid aging. According to a 2016 study in the Journal of Internal Medicine, Alzheimer’s Disease (AD) is the most common neurodegenerative disorder in Asia and comprises of over 60%…

…undergo rapid aging. According to a 2016 study in the Journal of Internal Medicine, Alzheimer’s Disease (AD) is the most common neurodegenerative disorder in Asia and comprises of over 60%…

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European Union Flag

3-D Printing: Forgotten by the New EU Medical Device Regulation?

By Emmanuel Garnier, Pierre-Alexis Maingon

…would manufacture custom-made devices using 3D printing – could be real competitors on the MD market in comparison with industrial firms that must comply with CE marking procedures. This risk…

…would manufacture custom-made devices using 3D printing – could be real competitors on the MD market in comparison with industrial firms that must comply with CE marking procedures. This risk…

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MDSAP, medical device single audit program

Medical Device Single Audit Program: Compliance and Opportunity

By Peter Rose

…navigate the compliance pathway, link up with experts and deliver the maximum commercial benefits from the process. Audit Cycle The MDSAP implementation cycle is staged as follows, typically over three…

…navigate the compliance pathway, link up with experts and deliver the maximum commercial benefits from the process. Audit Cycle The MDSAP implementation cycle is staged as follows, typically over three…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Is Your Establishmentā€™s Website Problematic?

By Dr. Christopher Joseph Devine

…noting concerns and perceived compliance issues. Warning Letter Excerpt Introduction – “FDA has reviewed your firm’s current website (www.dynavisioninternational.com/) as noted in the below examples and determined that the Dynavision…

…noting concerns and perceived compliance issues. Warning Letter Excerpt Introduction – “FDA has reviewed your firm’s current website (www.dynavisioninternational.com/) as noted in the below examples and determined that the Dynavision…

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Asia Medical Aesthetics Market Overview

By Ames Gross

…2016 10K report, the company’s sales in the Asia Pacific excluding Japan (APEJ) region increased by 41%, compared to its 21% global average. MEDICAL TOURISM FOR AESTHETICS Medical tourism has…

…2016 10K report, the company’s sales in the Asia Pacific excluding Japan (APEJ) region increased by 41%, compared to its 21% global average. MEDICAL TOURISM FOR AESTHETICS Medical tourism has…

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gavel

Medical Device Software & Products Liability: An Overview (Part I)

By Sara E. Dyson, Esq.

…$5.5 billion in 2014, but the increasing frequency of cyber attacks, regulatory and security compliance requirements, and data leaks have forced life sciences companies to dedicate more financial resources to…

…$5.5 billion in 2014, but the increasing frequency of cyber attacks, regulatory and security compliance requirements, and data leaks have forced life sciences companies to dedicate more financial resources to…

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