Cloud based solutions in the medical device industry

Weighing the Risks and Benefits of the Cloud

By Maria Fontanazza

…and to a company’s brand Device companies have many questions on the security side, because it seems like they have less control when using cloud solutions. They feel like they…

…and to a company’s brand Device companies have many questions on the security side, because it seems like they have less control when using cloud solutions. They feel like they…

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Japanese market, MedTech Intelligence

How to Succeed in Japan’s Medical Device Market

By Ames Gross

…in Japan. For example, if a device company conducts the proper market research and determines that the potential market size for the product in Japan is $10 million in five…

…in Japan. For example, if a device company conducts the proper market research and determines that the potential market size for the product in Japan is $10 million in five…

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Jessica Holmes, Argenta Advisors
Reimbursement Report

Transition to ICD-10: Potential Challenges & Benefits for U.S. Payers

By Jessica Holmes

…level, the International Classification of Diseases is a system developed by the World Health Organization (WHO) that uses a common coding language to report, accumulate and compare health care information…

…level, the International Classification of Diseases is a system developed by the World Health Organization (WHO) that uses a common coding language to report, accumulate and compare health care information…

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Open Innovation

The Best Pre-Prototype Strategies

By Terri Marion

…15, 2015). Communities of practice – a brief introduction. Wenger-Trayner. Retrieved from http://wenger-trayner.com/introduction-to-communities-of-practice/ Peter A. Koen, H. M. (May-June, 2014). Managing the Front End of Innovation—Part II. Research-Technology Management ….

…15, 2015). Communities of practice – a brief introduction. Wenger-Trayner. Retrieved from http://wenger-trayner.com/introduction-to-communities-of-practice/ Peter A. Koen, H. M. (May-June, 2014). Managing the Front End of Innovation—Part II. Research-Technology Management ….

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

eMDRs Part Deux: FDA on a Mission

By Dr. Christopher Joseph Devine

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 26, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Cellestis, Inc.. Accessed September 9, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm461128.htm…

…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (August 26, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Cellestis, Inc.. Accessed September 9, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm461128.htm…

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Pre-Prototype Stages, new product development process

The Power of Pre-Prototype

By Terri Marion

…product development process. New product development (NPD) refers to the complete process of bringing a new product to market—whether it is a new, breakthrough technology or a minor, incremental modification…

…product development process. New product development (NPD) refers to the complete process of bringing a new product to market—whether it is a new, breakthrough technology or a minor, incremental modification…

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Product development roles and responsibilities in medical device manufacturing

How to Create Effective Relationships with Your Development Partner

By Art Rousmaniere

…process guidelines to help the development partner complete the design. Stretching manufacturing technologies. Most new products can still be made using standard components and manufacturing processes and industry-standard tolerances. More…

…process guidelines to help the development partner complete the design. Stretching manufacturing technologies. Most new products can still be made using standard components and manufacturing processes and industry-standard tolerances. More…

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Josh Cannon, UPS, Optimizing supply chain inventory

Optimizing Inventory Management for Medical Devices

…at smaller companies, they tend to be more agile, so they embrace technology faster than normal because they’re fighting for market position. Conversely, many of the larger medical device companies…

…at smaller companies, they tend to be more agile, so they embrace technology faster than normal because they’re fighting for market position. Conversely, many of the larger medical device companies…

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

eMDRs: Fix Your SOPs Now

By Dr. Christopher Joseph Devine

…it at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm. Compliance for Dummies Now for those of you who are unfamiliar with the eMDR process, you will have so much fun setting up the accounts for your…

…it at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm. Compliance for Dummies Now for those of you who are unfamiliar with the eMDR process, you will have so much fun setting up the accounts for your…

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Roberta Goode and Julie Cabezas, Goode Compliance International

Considerations When Using Postmarket Data in Risk Management

By Roberta Goode, Julie Cabezas

The following article is Part II of “The Integration of Complaint Handling and Risk Management”. The key to integrating complaint handling and risk management is to ensure feeder processes are…

The following article is Part II of “The Integration of Complaint Handling and Risk Management”. The key to integrating complaint handling and risk management is to ensure feeder processes are…

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