In today’s healthcare world, every day there’s news about a new medical device that’s been made using 3-D printing technology. Broadly speaking, manufacturing devices using 3-D printing, or additive manufacturing…
In today’s healthcare world, every day there’s news about a new medical device that’s been made using 3-D printing technology. Broadly speaking, manufacturing devices using 3-D printing, or additive manufacturing…
…is clearly the final goal. Without it, commercialization stalls. The following blog is the third in a series of posts that examines the relationship between reimbursement and regulatory approval. Last…
…is clearly the final goal. Without it, commercialization stalls. The following blog is the third in a series of posts that examines the relationship between reimbursement and regulatory approval. Last…
…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, October). FDA.gov Website. Retrieved October 27, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418730.htm….
…key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA’s enforcement page. (2014, October). FDA.gov Website. Retrieved October 27, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm418730.htm….
…be compelling enough to highlight the fact that a well-established injection molding company that has been setting the industry standards for the past several decades would be a wise choice….
…be compelling enough to highlight the fact that a well-established injection molding company that has been setting the industry standards for the past several decades would be a wise choice….
…Device electrical and mechanical safety continues to be a critical path on the road to regulatory approvals and ongoing compliance. Q: I heard there are new regulations for batteries used…
…Device electrical and mechanical safety continues to be a critical path on the road to regulatory approvals and ongoing compliance. Q: I heard there are new regulations for batteries used…
…Smaller Cities Competition is already fierce among Western medical device companies trying to market their cancer products to top tier hospitals in large cities like Beijing and Shanghai. Therefore, companies…
…Smaller Cities Competition is already fierce among Western medical device companies trying to market their cancer products to top tier hospitals in large cities like Beijing and Shanghai. Therefore, companies…
…U.S., both small companies developing niche technologies, and big traditional companies, are looking at healthcare and asking ‘how can we do that.’ This challenge, combined with the dynamics of developing…
…U.S., both small companies developing niche technologies, and big traditional companies, are looking at healthcare and asking ‘how can we do that.’ This challenge, combined with the dynamics of developing…
…service performed; and The test and inspection data. Compliance for Dummies Dr. D would like to start with the comment, it is a pretty difficult task to comply with §820.200(b);…
…service performed; and The test and inspection data. Compliance for Dummies Dr. D would like to start with the comment, it is a pretty difficult task to comply with §820.200(b);…
…cannot use random examples to substantiate your device, but FDA can use it to ask questions, so while this cannot be a basis of your benefit-risk assessment, it will be…
…cannot use random examples to substantiate your device, but FDA can use it to ask questions, so while this cannot be a basis of your benefit-risk assessment, it will be…
…management is finally accepted as a continuing process of improvement.” New standards now require explicit risk management for biocompatibility, environmental control, usability, electromagnetic compatibility, electrical safety etc. So we have…
…management is finally accepted as a continuing process of improvement.” New standards now require explicit risk management for biocompatibility, environmental control, usability, electromagnetic compatibility, electrical safety etc. So we have…
