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

FDA and DOJ Working Together: No If, Ands or ā€˜Buttsā€™!

By Dr. Christopher Joseph Devine

Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Colombian national charged for unlawfully injecting silicone into victims’ bodies. Accessed August 01, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm514579.htm…

Compliance. Charleston, SC: Amazon. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Colombian national charged for unlawfully injecting silicone into victims’ bodies. Accessed August 01, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm514579.htm…

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Medtech question

I Changed My Medical Device. Do I Need to Submit a 510(k)?

By MedTech Intelligence Staff

…manufacturers of devices “subject to premarket notification requirements who intend to modify a 510(k)-cleared device or a preamendments devices subject to 510(k) during the process of deciding whether the modification…

…manufacturers of devices “subject to premarket notification requirements who intend to modify a 510(k)-cleared device or a preamendments devices subject to 510(k) during the process of deciding whether the modification…

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Protecting Data from Hackers a Rising Concern

By Maria Fontanazza

companies and more accountability placed on a company’s board of directors when data breaches occur. As a result, companies should be implementing processes now to try to get in front…

companies and more accountability placed on a company’s board of directors when data breaches occur. As a result, companies should be implementing processes now to try to get in front…

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Ameing for Asia

Opportunities and Pitfalls in Chinaā€™s Medical Device Market

By Ames Gross

…is more complicated now than ever before. Opportunities for Success. Despite the factors discussed, it is possible for device companies to succeed in China. The best way to go, despite…

…is more complicated now than ever before. Opportunities for Success. Despite the factors discussed, it is possible for device companies to succeed in China. The best way to go, despite…

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

MDRs: Establish a Procedure

By Dr. Christopher Joseph Devine

…non-compliance (duh) due to a failure script a procedure, script a fully compliant procedure, failure to implement a procedure, and failure to routinely comply with a procedure (e.g., establish). That…

…non-compliance (duh) due to a failure script a procedure, script a fully compliant procedure, failure to implement a procedure, and failure to routinely comply with a procedure (e.g., establish). That…

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Joachim Schaefer
Soapbox

What Medical Breakthroughs Will the Future Bring?

By Joachim SchƤfer

…methods can be developed for an increasing number of tests. Small, Complex and Powerful Manufacturers of minimally invasive surgical instruments continue to innovate. A COMPAMED exhibitor recently presented an MRI-compatible…

…methods can be developed for an increasing number of tests. Small, Complex and Powerful Manufacturers of minimally invasive surgical instruments continue to innovate. A COMPAMED exhibitor recently presented an MRI-compatible…

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FDA

FDA Explains Role of Real-World Evidence in Regulatory Decisions

By MedTech Intelligence Staff

…would build on and leverage the vast amount of data and information collected during the treatment and management of patients.” There is a 90-day comment period for the draft guidance….

…would build on and leverage the vast amount of data and information collected during the treatment and management of patients.” There is a 90-day comment period for the draft guidance….

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Mitigating Global Supply Chain Risks

By Maria Fontanazza

…chain strategies that device companies should implement when doing business at a global level. Regulatory compliance has been a top supply chain concern for device manufacturers, says Josh Cannon, director…

…chain strategies that device companies should implement when doing business at a global level. Regulatory compliance has been a top supply chain concern for device manufacturers, says Josh Cannon, director…

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Boston Scientific

Boston Scientific Acquisition Beefs Up Neuromodulation Business

By MedTech Intelligence Staff

In a move to expand its neuromodulation portfolio, Boston Scientific has acquired Cosman Medical for an undisclosed amount. The privately held company manufactures radiofrequency ablation systems for neurosurgery and pain…

In a move to expand its neuromodulation portfolio, Boston Scientific has acquired Cosman Medical for an undisclosed amount. The privately held company manufactures radiofrequency ablation systems for neurosurgery and pain…

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Heart

Update on the Cardiovascular Market in Asia

By Ames Gross

…In response to this competition, some Western cardiovascular companies are coming out with new “valve-oriented” devices. Microport and Lepu Medical, $2 billion-dollar Chinese medtech companies, are leading developers of CVD…

…In response to this competition, some Western cardiovascular companies are coming out with new “valve-oriented” devices. Microport and Lepu Medical, $2 billion-dollar Chinese medtech companies, are leading developers of CVD…

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