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

What’s So Darn Difficult about Writing a Form 483 Response?

By Dr. Christopher Joseph Devine

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 17, 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Terumo Medical Corp. Accessed March 23, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm491287.htm…

…system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 17, 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Terumo Medical Corp. Accessed March 23, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm491287.htm…

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Japanese market, MedTech Intelligence

Japan Expands Proactive Measures to Fight Cancer Market

By Ames Gross

…Annual Joint Conference on Breakthroughs in Cancer Research. These two institutions have served as important centers for advancing cancer research in Japan. The Japan Agency for Medical Research and Development…

…Annual Joint Conference on Breakthroughs in Cancer Research. These two institutions have served as important centers for advancing cancer research in Japan. The Japan Agency for Medical Research and Development…

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Mickey Garcia, MasterControl
MEDdesign

QMS Doesn’t Have to Be So Difficult

By Mickey Garcia

…needed in the original specification or procedure. Simplifying QMS to Improve Quality Management Historically, adopting an electronic QMS has been a complex, complicated effort for medtech companies. QMS software providers…

…needed in the original specification or procedure. Simplifying QMS to Improve Quality Management Historically, adopting an electronic QMS has been a complex, complicated effort for medtech companies. QMS software providers…

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

Three Strikes Equals a Warning Letter

By Dr. Christopher Joseph Devine

…evidence of compliance? Seriously, the FDA expects: (a) a containment statement, (b) a realistic plan to achieve compliance, (c) actual documented evidence to support compliance has been achieved, and (d)…

…evidence of compliance? Seriously, the FDA expects: (a) a containment statement, (b) a realistic plan to achieve compliance, (c) actual documented evidence to support compliance has been achieved, and (d)…

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Mayo Clinic

Boston Scientific, Mayo Clinic Team Up to Hit Unmet Needs

By MedTech Intelligence Staff

…an example of our commitment to further investing in jobs and innovation as a result of the recent suspension of the medical device tax.” Last year Mayo Clinic treated about…

…an example of our commitment to further investing in jobs and innovation as a result of the recent suspension of the medical device tax.” Last year Mayo Clinic treated about…

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Michael Lohan, IDA Ireland
Soapbox

Recruiting Tomorrow’s Medtech Workforce: Insights from Ireland

By Michael Lohan

…foster a competitive environment for skilled foreign workers and companies. Offering advantages such as a 12.5% tax on corporate trading activities has helped Ireland attract medtech companies in traditional as…

…foster a competitive environment for skilled foreign workers and companies. Offering advantages such as a 12.5% tax on corporate trading activities has helped Ireland attract medtech companies in traditional as…

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Cybersecurity, mhealth

Moving Target: Playing Catch-Up in Cybersecurity

By Maria Fontanazza

Cybersecurity is a moving target across every industry. Although not a new concept in medical devices, the maturity level is comparatively low versus other business sectors. One of the biggest…

Cybersecurity is a moving target across every industry. Although not a new concept in medical devices, the maturity level is comparatively low versus other business sectors. One of the biggest…

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

SCARs: Establishment Issued and FDA Induced

By Dr. Christopher Joseph Devine

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Repro-Med Systems, Inc….

…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Repro-Med Systems, Inc….

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Germany medtech

Medtech in Germany Remains Strong and Steady

By Maria Fontanazza

…and decision-support systems. Another prominent field is bio-hybrid systems where technical and biological components are combined as hybrid implant solutions for cardiovascular deficiencies or cartilage defects. MTI: What incentives does…

…and decision-support systems. Another prominent field is bio-hybrid systems where technical and biological components are combined as hybrid implant solutions for cardiovascular deficiencies or cartilage defects. MTI: What incentives does…

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Ameing for Asia

Steady Improvements to Medical Device Quality in China

By Ames Gross

…aggressive stance toward improving quality at local device companies via new regulations. The major regulations are outlined in Table 1. December 2014 The CFDA released two pieces of legislation that…

…aggressive stance toward improving quality at local device companies via new regulations. The major regulations are outlined in Table 1. December 2014 The CFDA released two pieces of legislation that…

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