Ameing for Asia

Key Regulatory Issues for Establishing New Green Field Device Factory in China

By Ames Gross

…when launching a new medical device manufacturing site in China, companies must obtain a number of basic regulatory approvals. These approvals include: Business License Product Notification Record (for Class I…

…when launching a new medical device manufacturing site in China, companies must obtain a number of basic regulatory approvals. These approvals include: Business License Product Notification Record (for Class I…

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Does Your Supply Chain Challenge the Status Quo?

…to patient. Only 44% of medical device companies have a UDI strategy in place, according to a recent study. Pricing pressures Increasing competition by generic medical devices, combined with the…

…to patient. Only 44% of medical device companies have a UDI strategy in place, according to a recent study. Pricing pressures Increasing competition by generic medical devices, combined with the…

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Joely Gardner, President and CEO, Human Factors Research

Will Your IFU Meet Usability Requirements?

By Joely Gardner

…Industry and FDA Reviewers. Retrieved from www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070801.pdf References National Center for Education Statistics, The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy. Retrieved from…

…Industry and FDA Reviewers. Retrieved from www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070801.pdf References National Center for Education Statistics, The Health Literacy of America’s Adults: Results from the 2003 National Assessment of Adult Literacy. Retrieved from…

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MobileODT, Clinician uses device

Mobile Technology Ready to Change Standard of Care in Cervical Cancer Detection

By Maria Fontanazza

…in East Africa. The company is also one of four finalists in the MedTech Innovator 2015 Competition. Selected out of 300 companies, MobileODT and the other finalists had to demonstrate…

…in East Africa. The company is also one of four finalists in the MedTech Innovator 2015 Competition. Selected out of 300 companies, MobileODT and the other finalists had to demonstrate…

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

If It Walks Like a Duck and Quacks Like a Duck It’s Probably a Duck

By Dr. Christopher Joseph Devine

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 20, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, NCS Pearson. Accessed September 25, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463351.htm…

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 20, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, NCS Pearson. Accessed September 25, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm463351.htm…

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Medical devices market in Russia, Intertek

Regulatory Changes and Market Access for Medical Devices in Russia

By Mark Miska

…exporters need to be aware of multiple factors at play if they desire to enter this market. Beyond obtaining FDA approval and maintaining compliance to U.S. standards and certifications, there…

…exporters need to be aware of multiple factors at play if they desire to enter this market. Beyond obtaining FDA approval and maintaining compliance to U.S. standards and certifications, there…

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Jon Speer, Greenlight.guru
Soapbox

4 Reasons Your Risk Management Approach is Wrong

By Jon Speer

…save you time in the long run. The risk management documentation actually serves multiple purposes, including: Communicating to your product development team and company management the risks involved with the…

…save you time in the long run. The risk management documentation actually serves multiple purposes, including: Communicating to your product development team and company management the risks involved with the…

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Carl Fischer, FDA, CDRH, Complaints, MedTech Intelligence

What Are Complaints and How Does FDA Handle Them?

By MedTech Intelligence Staff

“Inherently, complaints are just information—they’re pieces of information that come to FDA; they’re pieces of information that come to you as manufacturers,” according to Carl Fischer, Ph.D., director, Division of…

“Inherently, complaints are just information—they’re pieces of information that come to FDA; they’re pieces of information that come to you as manufacturers,” according to Carl Fischer, Ph.D., director, Division of…

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Maria Fontanazza, Editor-in-Chief, MedTechIntelligence.com
From The Editor's Desk

What You Do Beyond Compliance Matters

By Maria Fontanazza

…organizations across the globe (the folks who manage complaints) understand how to speak to the company’s commercial organization. “What’s the language that’s going to connect with your commercial partners? What’s…

…organizations across the globe (the folks who manage complaints) understand how to speak to the company’s commercial organization. “What’s the language that’s going to connect with your commercial partners? What’s…

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

One, Two, Three Strikes You’re Out…Or, Receive a Warning Letter

By Dr. Christopher Joseph Devine

…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 9, 2015). Inspections, Compliance, Enforcement, and Criminal…

…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 9, 2015). Inspections, Compliance, Enforcement, and Criminal…

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