…in the field- especially for novel devices in medical specialty areas, manufacturing and supply chain management all add significantly to the raw cost of goods. Carefully consider any reimbursement model…
…in the field- especially for novel devices in medical specialty areas, manufacturing and supply chain management all add significantly to the raw cost of goods. Carefully consider any reimbursement model…
…21 CFR, Part 820.198 (a) (3) under “Complaint Files” points directly to 21 CFR, Part 803 and the need to review complaints and determine if adverse events are reportable to…
…21 CFR, Part 820.198 (a) (3) under “Complaint Files” points directly to 21 CFR, Part 803 and the need to review complaints and determine if adverse events are reportable to…
…companies that need metal components such as surgical staples or flat springs in staple guns, etc. as well as commercial products such as clips, connectors, and various other metal formed…
…companies that need metal components such as surgical staples or flat springs in staple guns, etc. as well as commercial products such as clips, connectors, and various other metal formed…
Seriously, a company decides to just start selling a medical device on the U. S. Market without obtaining FDA clearance in advance? Seriously, a company actually believes that they can…
Seriously, a company decides to just start selling a medical device on the U. S. Market without obtaining FDA clearance in advance? Seriously, a company actually believes that they can…
…Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Warning Letters – Inspections, Compliance, Enforcement, and Criminal Investigations. (2013, December). Retrieved…
…Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Warning Letters – Inspections, Compliance, Enforcement, and Criminal Investigations. (2013, December). Retrieved…
…19, 2014, from http://www.fda.gov/downloads/iceci/enforcementactions/enforcementstory/ucm129820 Food and Drug Administration Office of Criminal Investigations. (2011, November). FDA Website. Retrieved January 19, 2014, from http://www.fda.gov/iceci/criminalinvestigations/ucm280937.htm. Office of Criminal Investigations – the enforcement story….
…19, 2014, from http://www.fda.gov/downloads/iceci/enforcementactions/enforcementstory/ucm129820 Food and Drug Administration Office of Criminal Investigations. (2011, November). FDA Website. Retrieved January 19, 2014, from http://www.fda.gov/iceci/criminalinvestigations/ucm280937.htm. Office of Criminal Investigations – the enforcement story….
…Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003). Warning Letters – Inspections, Compliance, Enforcement, and Criminal Investigations. (2013, December). Retrieved December 30, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm379092.htm….
…Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003). Warning Letters – Inspections, Compliance, Enforcement, and Criminal Investigations. (2013, December). Retrieved December 30, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm379092.htm….
…are required to comply with, not having sufficient resources to sustain compliance is a recurring nightmare for Chief Jailable Officers (CJO) everywhere. That being said, the doctor hopes you enjoy…
…are required to comply with, not having sufficient resources to sustain compliance is a recurring nightmare for Chief Jailable Officers (CJO) everywhere. That being said, the doctor hopes you enjoy…
…pipe dream. Important dates for compliance The following dates are immensely important when it comes to UDI compliance for Q4-2013 and beyond. For starters, December 18th is extremely important. It…
…pipe dream. Important dates for compliance The following dates are immensely important when it comes to UDI compliance for Q4-2013 and beyond. For starters, December 18th is extremely important. It…
…Part 11 compliant. Finally, any system designed to meet the intent of Part 11 compliance must be properly validated. The purpose of the validation is to ensure: Any changes made…
…Part 11 compliant. Finally, any system designed to meet the intent of Part 11 compliance must be properly validated. The purpose of the validation is to ensure: Any changes made…
