Asia

Demand Skyrockets for Oncology Products in Asian Markets

By Ames Gross

…taking advantage of Asia’s high-growth cancer market by tailoring research to the region and collaborating with local partners and research centers. For example, Novartis is partnering with regional research centers…

…taking advantage of Asia’s high-growth cancer market by tailoring research to the region and collaborating with local partners and research centers. For example, Novartis is partnering with regional research centers…

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UL LLC

Ask the Expert: EU Regulations and Clarification for Products Used in Day Spas

…the new UE Medical Device Regulations at: http://library.ul.com/?document=the-changing-landscape-of-medical-and-in-vitro-diagnostic-device-regulations-in-the-european-union Q: We produce products that are used in medical day spas. Are these required to have FDA approval and UL Certification? A:…

…the new UE Medical Device Regulations at: http://library.ul.com/?document=the-changing-landscape-of-medical-and-in-vitro-diagnostic-device-regulations-in-the-european-union Q: We produce products that are used in medical day spas. Are these required to have FDA approval and UL Certification? A:…

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How to CE Mark a Medical Device that Incorporates a Drug

By Paula McCarthy

…ancillary human blood derivative, MEDDEV 2.1/3. Retrieved from http://ec.europa.eu/growth/sectors/medical-devices_old/documents/guidelines/files/meddev/2_1_3_rev_3-12_2009_en.pdf European Commission. (July 2014) Manual on borderline and classification in the community. Regulatory framework for medical devices. Retrieved from http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf MHRA….

…ancillary human blood derivative, MEDDEV 2.1/3. Retrieved from http://ec.europa.eu/growth/sectors/medical-devices_old/documents/guidelines/files/meddev/2_1_3_rev_3-12_2009_en.pdf European Commission. (July 2014) Manual on borderline and classification in the community. Regulatory framework for medical devices. Retrieved from http://ec.europa.eu/health/medical-devices/files/wg_minutes_member_lists/borderline_manual_ol_en.pdf MHRA….

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Could the Pope Give You a Heart Attack?

By Maria Fontanazza

…said Pamela Alpin, Sales Manager at HeartSine Technologies, in a news release. While it is important that these potentially life-saving devices are available in public places, proper training is recommended…

…said Pamela Alpin, Sales Manager at HeartSine Technologies, in a news release. While it is important that these potentially life-saving devices are available in public places, proper training is recommended…

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

Only Two Form 483 Observations Can Equate to a Warning Letter

By Dr. Christopher Joseph Devine

…take short cuts and as Larry the Cable Guy routinely pontificates, “Get’er Done!” Furthermore, oral complaints are complaints, and they shall be documented accordingly. Finally, as part of the complaint…

…take short cuts and as Larry the Cable Guy routinely pontificates, “Get’er Done!” Furthermore, oral complaints are complaints, and they shall be documented accordingly. Finally, as part of the complaint…

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Top Procurement Strategies to Enhance Profitability

To remain competitive in today’s global marketplace, the smartest medical device manufacturers are broadening their perspectives when it comes to contract manufacturing strategies for new product introductions. They are moving…

To remain competitive in today’s global marketplace, the smartest medical device manufacturers are broadening their perspectives when it comes to contract manufacturing strategies for new product introductions. They are moving…

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Jessica Holmes, Argenta Advisors
Reimbursement Report

The Best Value Proposition. Ever.

By Jessica Holmes

New Normal. By integrating the impact of new care delivery and payment models in the approach to commercialization and value proposition development, medical technology companies can demonstrate their true value…

New Normal. By integrating the impact of new care delivery and payment models in the approach to commercialization and value proposition development, medical technology companies can demonstrate their true value…

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

If Hackers Can Commandeer a Car, Why not a Medical Device?

By Dr. Christopher Joseph Devine

…selection/input. (October 2012). Accessed August 3, 2015. Retrieved from http://www.fda.gov/safety/recalls/ucm326131.htm Symbiq Infusion System by Hospira: FDA safety communication – cybersecurity vulnerabilities. (July 2015). Accessed July 31, 2015. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm456832.htm…

…selection/input. (October 2012). Accessed August 3, 2015. Retrieved from http://www.fda.gov/safety/recalls/ucm326131.htm Symbiq Infusion System by Hospira: FDA safety communication – cybersecurity vulnerabilities. (July 2015). Accessed July 31, 2015. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm456832.htm…

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Alert

Hack Alert: Infusion Pump Security at Risk

By MedTech Intelligence Staff

…System. On Friday FDA issued a safety communication alert related to this product and advised any healthcare facilities that are currently using it to “transition to alternative systems”. The issue:…

…System. On Friday FDA issued a safety communication alert related to this product and advised any healthcare facilities that are currently using it to “transition to alternative systems”. The issue:…

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What Do FDA Investigators Look for During an Inspection?

By Maria Fontanazza

When preparing for an inspection, it’s important to remember that you’re the expert of your combination product, according to Melanie Drayton, managing consultant at Navigant. “That means you need to…

When preparing for an inspection, it’s important to remember that you’re the expert of your combination product, according to Melanie Drayton, managing consultant at Navigant. “That means you need to…

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