I begin this edition of Devine Guidance (DG) by reinforcing the importance of DG Rule #1 – Compliance to regulations is not optional, compliance is mandatory and dictated by law….
I begin this edition of Devine Guidance (DG) by reinforcing the importance of DG Rule #1 – Compliance to regulations is not optional, compliance is mandatory and dictated by law….
…requirements, as required by 21 C.F.R. 820.90(a). For example, you identified a higher incidence of nonconforming product in November 2008 through complaints filed for ovalizing and kinking of the Neuron…
…requirements, as required by 21 C.F.R. 820.90(a). For example, you identified a higher incidence of nonconforming product in November 2008 through complaints filed for ovalizing and kinking of the Neuron…
…not as common as injection molding vendors. Sheet metal: Many low-volume enclosures are made from sheet metal because the tooling cost is very low for a basic shape. The tradeoff…
…not as common as injection molding vendors. Sheet metal: Many low-volume enclosures are made from sheet metal because the tooling cost is very low for a basic shape. The tradeoff…
…maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall: (1) Evaluate and select potential suppliers, contractors, and consultants on the basis…
…maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall: (1) Evaluate and select potential suppliers, contractors, and consultants on the basis…
…be evaluated; however, the path to compliance is remanded back to the medical device manufacturer. The key for compliance, to regulations and standards, is to establish and spell out in…
…be evaluated; however, the path to compliance is remanded back to the medical device manufacturer. The key for compliance, to regulations and standards, is to establish and spell out in…
…Retrieved February 12, 2010, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ Foxton, J. (1996). Negotiating quality through customer communications. Managing Service Quality, 6(5). Retrieved November 5, 2008, from http://proquest.umi.com Medical Device Directive. (1993). Council Directive…
…Retrieved February 12, 2010, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ Foxton, J. (1996). Negotiating quality through customer communications. Managing Service Quality, 6(5). Retrieved November 5, 2008, from http://proquest.umi.com Medical Device Directive. (1993). Council Directive…
…complies with the various regulations. Believe me, the medical device industry grows more complex by the day due to the ongoing evolution of regulations. For example, we are all familiar…
…complies with the various regulations. Believe me, the medical device industry grows more complex by the day due to the ongoing evolution of regulations. For example, we are all familiar…
…of a non-conforming component or the rejection of an acceptable component. According to Mehta and Kauffman, “normally, for the acceptable measuring system, no more than 9 percent of the tolerance…
…of a non-conforming component or the rejection of an acceptable component. According to Mehta and Kauffman, “normally, for the acceptable measuring system, no more than 9 percent of the tolerance…
…specification. The process commences with the supplier and the manufacturer agreeing on the data and format, completing the FAI, and then analyzing the data for accuracy and correlation. The concept…
…specification. The process commences with the supplier and the manufacturer agreeing on the data and format, completing the FAI, and then analyzing the data for accuracy and correlation. The concept…
…the FDA, MHLW, Health Canada, Competent Authorities in the EU, or your notified body. If you are willing to do so, please commit the following question to memory: Where do…
…the FDA, MHLW, Health Canada, Competent Authorities in the EU, or your notified body. If you are willing to do so, please commit the following question to memory: Where do…
