…replied that his company had met with many Japanese KOLs, and they all said that his company’s product was terrific. When I probed deeper, I learned that his company obtained…
…replied that his company had met with many Japanese KOLs, and they all said that his company’s product was terrific. When I probed deeper, I learned that his company obtained…
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (July 2015). Accessed July 28, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm455224.htm…
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (July 2015). Accessed July 28, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm455224.htm…
…Combination Product Approved Under BLA, NDA, or PMA Other activities Inter-Center Consult Process Study (analysis is almost complete) Communication enhancements to Combination Product IT Database Inter-Center review and compliance procedure…
…Combination Product Approved Under BLA, NDA, or PMA Other activities Inter-Center Consult Process Study (analysis is almost complete) Communication enhancements to Combination Product IT Database Inter-Center review and compliance procedure…
…for a cup of coffee and an inspection. Please keep in mind, the agency has no problem with foisting (look-it-up) their beliefs upon medical device companies that fail to comply…
…for a cup of coffee and an inspection. Please keep in mind, the agency has no problem with foisting (look-it-up) their beliefs upon medical device companies that fail to comply…
…formative evaluation, this is the foundation for usability research and the basis for initial concepts. It is comprised of analytical-based research that focuses on identifying relevant standards, user populations, characteristics,…
…formative evaluation, this is the foundation for usability research and the basis for initial concepts. It is comprised of analytical-based research that focuses on identifying relevant standards, user populations, characteristics,…
…ways the 21st Century Cures Act affects the medical device industry Combination products: Final guidance that outlines responsibilities of each agency during the review process (within 18 months of enactment)…
…ways the 21st Century Cures Act affects the medical device industry Combination products: Final guidance that outlines responsibilities of each agency during the review process (within 18 months of enactment)…
…from this non-compliant behavior. Always keep in mind Dr. D’s favorite quote; “There is no such thing as minimum compliance, there is no such thing as maximum compliance, there is…
…from this non-compliant behavior. Always keep in mind Dr. D’s favorite quote; “There is no such thing as minimum compliance, there is no such thing as maximum compliance, there is…
…medical device and examples of the MMAs cleared by FDA during the past 18 years, from the earliest digital recorders to the smartphone- and tablet-compatible AliveCor Heart Monitor. …
…medical device and examples of the MMAs cleared by FDA during the past 18 years, from the earliest digital recorders to the smartphone- and tablet-compatible AliveCor Heart Monitor. …
…adequately secured. For example, they may use default or common passwords given the expectation that internal hospital devices will only be used on the internal hospital networks. However, if an…
…adequately secured. For example, they may use default or common passwords given the expectation that internal hospital devices will only be used on the internal hospital networks. However, if an…
Regulatory executives from medical device companies often ask me about the best regulatory strategy for an Asian country and the timing to obtain registration approval. Before getting too far into…
Regulatory executives from medical device companies often ask me about the best regulatory strategy for an Asian country and the timing to obtain registration approval. Before getting too far into…
