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

Statistical Techniques: Zero for 11

By Dr. Christopher Joseph Devine

…quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. DMP ,Ltd. Accessed April 13, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497069.htm….

…quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (March 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. DMP ,Ltd. Accessed April 13, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm497069.htm….

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Parminder Kalle, Maetrics

Eight Steps to Post-Market Surveillance Compliance

By Parminder Kalle

communication open between customers who have already filed a complaint and the business in order to garner all necessary information about relevant complaints and understand if there is any scope…

communication open between customers who have already filed a complaint and the business in order to garner all necessary information about relevant complaints and understand if there is any scope…

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Medical device recall

CDRH, Industry to Discuss Collaboration on HHE and Recalls

By MedTech Intelligence Staff

…Office of Compliance, and industry stakeholders will answer these questions at the upcoming MedTech Intelligence HHE and Recalls Conference (View the agenda), May 10–11, 2016 in Washington, DC. What’s new

…Office of Compliance, and industry stakeholders will answer these questions at the upcoming MedTech Intelligence HHE and Recalls Conference (View the agenda), May 10–11, 2016 in Washington, DC. What’s new

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Ameing for Asia

Multiple Paths to Success in Asian Markets

By Ames Gross

As a consultant, I often have interesting discussions with potential medtech clients. For example, a company with a relatively new medical technology recently asked if I could help them in…

As a consultant, I often have interesting discussions with potential medtech clients. For example, a company with a relatively new medical technology recently asked if I could help them in…

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Dollar, money

Medtech Powerhouse: Abbott to Acquire St. Jude for $25 Billion

By MedTech Intelligence Staff

…creates a market opportunity of nearly $30 billion. “Bringing together these two great companies will create a premier medical device business and immediately advance Abbott’s strategic and competitive position,” said…

…creates a market opportunity of nearly $30 billion. “Bringing together these two great companies will create a premier medical device business and immediately advance Abbott’s strategic and competitive position,” said…

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stethescope

Telemedicine in Asia Expands Horizon for Medtech Companies

By Ames Gross

…throughout Asia. Companies such as 3M, Thinklabs One, and Eko Devices produce digital stethoscopes, while the U.S. company TreVia has teamed up with the Italian company D-Eye to produce high-quality…

…throughout Asia. Companies such as 3M, Thinklabs One, and Eko Devices produce digital stethoscopes, while the U.S. company TreVia has teamed up with the Italian company D-Eye to produce high-quality…

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New Ventral Hernia Mesh Shoots to Kill Bacteria

By Maria Fontanazza

A Memphis-based start-up company wants to hit two key issues in the open hernia repair market: surgical site infection and cost-effective technology. Nearly 70% of ventral hernia repairs are open…

A Memphis-based start-up company wants to hit two key issues in the open hernia repair market: surgical site infection and cost-effective technology. Nearly 70% of ventral hernia repairs are open…

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Wearable Cloud, Medical Device Connectivity

Adding Connectivity to Your Medical Device

By Eric Soederberg

…availability, and cost constraints. Step Three. Implement the system components following compliant and proven robust development processes. Design and implement maintainable code, comply with coding standards, and comment well to…

…availability, and cost constraints. Step Three. Implement the system components following compliant and proven robust development processes. Design and implement maintainable code, comply with coding standards, and comment well to…

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

CJO Rides the Wave to Prison

By Dr. Christopher Joseph Devine

…Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA (April 4, 2016). Inspections, Compliance,…

…Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA (April 4, 2016). Inspections, Compliance,…

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Connecting User Needs with Actionable Product Design Inputs

By MedTech Intelligence Staff

…and senior partner at Insight Product Development, discusses this challenging area for medical device companies and how it needs to be aligned with a company’s ultimate business goals. https://youtu.be/NDhr-a8R3yc  …

…and senior partner at Insight Product Development, discusses this challenging area for medical device companies and how it needs to be aligned with a company’s ultimate business goals. https://youtu.be/NDhr-a8R3yc  …

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