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Ames Gross, Pacific Bridge Medical

Medical Device Companies Look East

By Ames Gross

…governments are increasingly working with Western hospitals and medical companies to launch treatment and research partnerships. For instance, Seattle’s Fred Hutchinson Cancer Research Center and Shanghai’s Center for Drug Control…

…governments are increasingly working with Western hospitals and medical companies to launch treatment and research partnerships. For instance, Seattle’s Fred Hutchinson Cancer Research Center and Shanghai’s Center for Drug Control…

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Fine Laser Cutting for Medical Components

By Geoff Shannon

…degrees. Laser cutting offers such off-axes cutting, where cut edges are angled to the surface, and can also accommodate compound angle cutting. Figure 5 shows examples of off-axes cutting of…

…degrees. Laser cutting offers such off-axes cutting, where cut edges are angled to the surface, and can also accommodate compound angle cutting. Figure 5 shows examples of off-axes cutting of…

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

Surprise – Device Establishments are Required to Pursue Acceptance Activities –Who Knew?

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. (2014, September). FDA.gov Website. Retrieved September 20, 2014, From http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/….

…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, September). FDA.gov Website. Retrieved September 20, 2014, From http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/….

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What Can Apps Do For Health?

By MedTech Intelligence Staff

…about MEDICA 2014 exhibitors, product information, company news and the accompanying conferences and forum programs (for example MEDICA HEALTH IT FORUM and MEDICA CONNECTED HEALTH FORUM), are available at http://www.medica-tradefair.com….

…about MEDICA 2014 exhibitors, product information, company news and the accompanying conferences and forum programs (for example MEDICA HEALTH IT FORUM and MEDICA CONNECTED HEALTH FORUM), are available at http://www.medica-tradefair.com….

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Are you Ready for a Notified Body Unannounced Audit?

By Sangita Viswanathan

…in place? Berlin Heart’s Heinze advises companies to look at their processes, past audit reports and issues such as non-conformances, and apply these to write new procedures for unannounced audits….

…in place? Berlin Heart’s Heinze advises companies to look at their processes, past audit reports and issues such as non-conformances, and apply these to write new procedures for unannounced audits….

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Ameing for Asia

7 Reasons Your Medical Device Company Should Be “Ameing” for Asia

By Ames Gross

…companies are available in Asia, many small to mid-size companies with unique technologies have still not penetrated the region. Small to mid-size medical device companies that are willing to deal…

…companies are available in Asia, many small to mid-size companies with unique technologies have still not penetrated the region. Small to mid-size medical device companies that are willing to deal…

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Innovative X-ray Technology – for Improved Breast Cancer Diagnosis

…x-ray imaging/ computer tomography, magnetic resonance tomography, ultrasound) are now online in the Company & Product category at http://www.medica-tradefair.com. New and approved approaches to oncological diagnosis and therapy will be…

…x-ray imaging/ computer tomography, magnetic resonance tomography, ultrasound) are now online in the Company & Product category at http://www.medica-tradefair.com. New and approved approaches to oncological diagnosis and therapy will be…

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

Surprise – Chief Jailable Officers Get Put in Jail

By Dr. Christopher Joseph Devine

…hefty sentences for fraud. Retrieved September 9, 2014, from http://www.meddeviceonline.com. United States v. Michael Baker and Michael Gluk Court Docket Number: 1:13-CR-00346-SS. (2014, August). Retrieved September 9, 2014, from http://www.justice.gov/criminal/vns/caseup/baker-gluk.html….

…hefty sentences for fraud. Retrieved September 9, 2014, from http://www.meddeviceonline.com. United States v. Michael Baker and Michael Gluk Court Docket Number: 1:13-CR-00346-SS. (2014, August). Retrieved September 9, 2014, from http://www.justice.gov/criminal/vns/caseup/baker-gluk.html….

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Robert Charles, Director and Principal Engineer, Farm

Creative Prototyping for Medical Device Product Development

…final design. The metal paradox Let’s now consider metal components. Machining and sheet metal fabrication are common production processes, and can be readily prototyped. Laser sintered metal parts are also…

…final design. The metal paradox Let’s now consider metal components. Machining and sheet metal fabrication are common production processes, and can be readily prototyped. Laser sintered metal parts are also…

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Reimbursement Report

FDA 510(k) Clearance and Third-Party Reimbursement

By Elizabeth Brown, MD

…reimbursement is clearly the final goal. Without it, commercialization stalls. The following blog is the first in a series of posts that examines the relationship between reimbursement and the type…

…reimbursement is clearly the final goal. Without it, commercialization stalls. The following blog is the first in a series of posts that examines the relationship between reimbursement and the type…

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