Medical device recall

Cook Medical Recalls Wire Guides Due to Potential Glass in Hydrophilic Coating

By MedTech Intelligence Staff

Recalls and other field actions are an unavoidable part of the medical device industry. Join MedTech Intelligence for MEDICAL DEVICE RECALLS: Procedures & Best Practices | November 14–15 in Boston,…

Recalls and other field actions are an unavoidable part of the medical device industry. Join MedTech Intelligence for MEDICAL DEVICE RECALLS: Procedures & Best Practices | November 14–15 in Boston,…

Continue reading

Product Development, Human factors engineering

HFE Practice Models: How Manufacturers Establish and Maintain HFE Competency

By Allison Strochlic, Michael Wiklund

…of higher-level HFE knowledge and strategy Potential for inconsistency among HFE methods and end-products (if engaging multiple consultants) Increased costs of engaging consultants as compared to leveraging internal resources Model…

…of higher-level HFE knowledge and strategy Potential for inconsistency among HFE methods and end-products (if engaging multiple consultants) Increased costs of engaging consultants as compared to leveraging internal resources Model…

Continue reading

Barcode, UDI

Preparing for UDI in Europe

By Steve Cottrell, Madris Tomes

…changes to comply with UDI’s compliance date in 2014.2 Non-Compliance Ramifications Manufacturers that do not adopt UDI should be aware of the severe consequences of not meeting compliance standards. The…

…changes to comply with UDI’s compliance date in 2014.2 Non-Compliance Ramifications Manufacturers that do not adopt UDI should be aware of the severe consequences of not meeting compliance standards. The…

Continue reading

Dollar, money

Controlling Costs an Issue in Product Development

By MedTech Intelligence Staff

REGISTER HERE for the free webinar, Accelerating MedTech Product Development | Monday, September 12, 2016 | 1 pm – 2:30 pm ET Medical devices undergo many changes, with improvements being…

REGISTER HERE for the free webinar, Accelerating MedTech Product Development | Monday, September 12, 2016 | 1 pm – 2:30 pm ET Medical devices undergo many changes, with improvements being…

Continue reading

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

Protect Your Investments!

By Dr. Christopher Joseph Devine

…why device companies would fail to protect their investments. For example, injection molding presses and five-axis CNC milling machines are expensive pieces of capital equipment. Common sense would dictate the…

…why device companies would fail to protect their investments. For example, injection molding presses and five-axis CNC milling machines are expensive pieces of capital equipment. Common sense would dictate the…

Continue reading

Mosquito, zika

Rocheā€™s Zika PCR Test Wins FDA Emergency Use Authorization

By MedTech Intelligence Staff

…been FDA cleared or approved; FDA has authorized its use by labs certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests. “The test has been…

…been FDA cleared or approved; FDA has authorized its use by labs certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests. “The test has been…

Continue reading

Intuitive Surgical, robotic assisted surgery

The Transformation of Robotics in Asia

By Ames Gross

…practice the skills necessary to operate surgical robots. Inspired by the renowned da Vinci system, the Meere Company in Korea has been developing the new Revo-i system since 2007. Revo-i…

…practice the skills necessary to operate surgical robots. Inspired by the renowned da Vinci system, the Meere Company in Korea has been developing the new Revo-i system since 2007. Revo-i…

Continue reading

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

Another CJO Convicted Courtesy of FDA and DOJ, Oh My!

By Dr. Christopher Joseph 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. (July 2016). Inspections, Compliance, Enforcement, and…

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

Continue reading

ISO_13485

Quick List: The Update on ISO 13485:2016

By Maria Fontanazza

72 times in the new standard as compared to only 16 times in the 2003 version), according to Roberta Goode, president and CEO of Goode Compliance International. During a recent…

72 times in the new standard as compared to only 16 times in the 2003 version), according to Roberta Goode, president and CEO of Goode Compliance International. During a recent…

Continue reading