Heart

Was Device Tax Responsible for 29k Job Loss?

By MedTech Intelligence Staff

…the U.S. medtech industry lost 28,834 jobs—a 7.2% decrease. The majority of job losses were seen in 2014, with the industry losing about 27,000 positions in the industry.   https://medtechintelligence.com/news_article/trumps-impact-pricing-rd-funding-cybersecurity-among-top-trends-new-year/…

…the U.S. medtech industry lost 28,834 jobs—a 7.2% decrease. The majority of job losses were seen in 2014, with the industry losing about 27,000 positions in the industry.   https://medtechintelligence.com/news_article/trumps-impact-pricing-rd-funding-cybersecurity-among-top-trends-new-year/…

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

Complaints, Complaints & Complaints: Is Anyone Listening?

By Dr. Christopher Joseph Devine

…bombarded with new requests for quotation. The good news is that an establishment’s customer base and the FDA can be placated if all of the complaints are recorded (including verbal…

…bombarded with new requests for quotation. The good news is that an establishment’s customer base and the FDA can be placated if all of the complaints are recorded (including verbal…

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Medtech, innovation

Speedy and Efficient Implementation of Medical and Healthcare Software

By Richard Lu

…EHR Association backs no FDA regulation for electronic health record systems. Retrieved from http://www.healthcareitnews.com/news/ehr-association-backs-no-fda-regulation-electronic-health-record-systems NiQ Health. (July 30, 2014). Unregulated medical devices used extensively across Australian hospitals. Retrieved from http://www.careplus-niqhealth.com.au/news/niq-health-reveals-the-extensive-use-of-unregulated-medical-devices-in-australian-hospitals.html…

…EHR Association backs no FDA regulation for electronic health record systems. Retrieved from http://www.healthcareitnews.com/news/ehr-association-backs-no-fda-regulation-electronic-health-record-systems NiQ Health. (July 30, 2014). Unregulated medical devices used extensively across Australian hospitals. Retrieved from http://www.careplus-niqhealth.com.au/news/niq-health-reveals-the-extensive-use-of-unregulated-medical-devices-in-australian-hospitals.html…

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Alert

FDA Confirms Cybersecurity Vulnerabilities with Certain St. Jude Medical ICDs

By MedTech Intelligence Staff

Medical device cybersecurity is a looming threat that often appears in the news. Hear industry experts discuss design, oversight, risk mitigation and containment at the Medical Device Cybersecurity conference, March…

Medical device cybersecurity is a looming threat that often appears in the news. Hear industry experts discuss design, oversight, risk mitigation and containment at the Medical Device Cybersecurity conference, March…

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Theranos Gets Rid of 41% of Staff

By MedTech Intelligence Staff

As if things couldn’t get worse for Theranos, the news came today that the company is cutting nearly 41% of its positions (155 employees), with only 220 staff remaining. According…

As if things couldn’t get worse for Theranos, the news came today that the company is cutting nearly 41% of its positions (155 employees), with only 220 staff remaining. According…

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

‘Play it Again Sam’: Bad News for a Device Establishment

By Dr. Christopher Joseph Devine

…user, regulatory and business). The higher the risk, the more controls are warranted. This is nothing more than old-fashion common sense, right? There is some good news to share with…

…user, regulatory and business). The higher the risk, the more controls are warranted. This is nothing more than old-fashion common sense, right? There is some good news to share with…

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

It’s Basic Blocking & Tackling

By Dr. Christopher Joseph Devine

…The good news is creating an audit schedule is left completely in the hands of the establishment. When scripting the annual audit schedule, audits can be planned for and executed…

…The good news is creating an audit schedule is left completely in the hands of the establishment. When scripting the annual audit schedule, audits can be planned for and executed…

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

Who’s on First?

By Dr. Christopher Joseph Devine

…establishment’s approved supplier’s List. The good news is that it is your establishment so you can script requirements for each contractor. If the establishment needs an auditor, then the expectation…

…establishment’s approved supplier’s List. The good news is that it is your establishment so you can script requirements for each contractor. If the establishment needs an auditor, then the expectation…

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

Trick or Treat: Warning Letters

By Dr. Christopher Joseph Devine

…for Dummies The good news for device establishments is that most software companies selling COTS into the device industry for document control, CAPA, calibration, etc. also provide appropriate validation tools….

…for Dummies The good news for device establishments is that most software companies selling COTS into the device industry for document control, CAPA, calibration, etc. also provide appropriate validation tools….

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