…FDA expects a DHR, that supports compliance with the DMR, to be completed using GDP; (a) FDA; (b) DHR; (c) DMR; and (d) GDP. Failure of the Chief Jailable Officer…
…FDA expects a DHR, that supports compliance with the DMR, to be completed using GDP; (a) FDA; (b) DHR; (c) DMR; and (d) GDP. Failure of the Chief Jailable Officer…
…being performed, i.e., limit versus challenge; Compiled list of equipment to be used; Training requirements (please note, validation activities should only be performed by qualified individuals; Data collection sheets; Sample…
…being performed, i.e., limit versus challenge; Compiled list of equipment to be used; Training requirements (please note, validation activities should only be performed by qualified individuals; Data collection sheets; Sample…
…been used) My mind raced back to the what questions to think about what process(es) were under investigation. That I knew! With that afternoon I had spent installing the TV…
…been used) My mind raced back to the what questions to think about what process(es) were under investigation. That I knew! With that afternoon I had spent installing the TV…
…operating procedures (SOP’s), and methods that define and control the manner of production; Monitoring and control of process parameters and component and device characteristics during production; Compliance with specified reference…
…operating procedures (SOP’s), and methods that define and control the manner of production; Monitoring and control of process parameters and component and device characteristics during production; Compliance with specified reference…
…In fact, the requirements for complying with 21 CFR, Part 820.30 (Design Controls) are clearly defined. If an establishment fails to comply with 21 CFR, Part 820.30, then their product…
…In fact, the requirements for complying with 21 CFR, Part 820.30 (Design Controls) are clearly defined. If an establishment fails to comply with 21 CFR, Part 820.30, then their product…
New regulatory guidance, especially those on human factors, has pushed classic medical device companies to include user experience (UX) and industrial design (ID) as part of the development process. Since…
New regulatory guidance, especially those on human factors, has pushed classic medical device companies to include user experience (UX) and industrial design (ID) as part of the development process. Since…
…the cows come home to open and complete a complaint investigation. Additionally, complaint activities must be “DOCUMENTED” as in documented in writing or some other form of print that supports…
…the cows come home to open and complete a complaint investigation. Additionally, complaint activities must be “DOCUMENTED” as in documented in writing or some other form of print that supports…
…to obey one of FDA’s basic commandments. In each case, no good can come out of a device establishment’s failure to comply with regulatory and statutory requirements. In the case…
…to obey one of FDA’s basic commandments. In each case, no good can come out of a device establishment’s failure to comply with regulatory and statutory requirements. In the case…
…other things, MRI compatible, and their efforts in developing primary cells that can be sterilized at 134C. Their new development in rechargeable lithium cells are designed for a 3,000 lifetime….
…other things, MRI compatible, and their efforts in developing primary cells that can be sterilized at 134C. Their new development in rechargeable lithium cells are designed for a 3,000 lifetime….
New law in Brazil changes enforcement of BGMP requirements for certain devices The Brazilian government has implemented a new law, RDC 15/2014 (link in Portuguese), that significantly eases the registration process for…
New law in Brazil changes enforcement of BGMP requirements for certain devices The Brazilian government has implemented a new law, RDC 15/2014 (link in Portuguese), that significantly eases the registration process for…
