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….
…Directive. (1993). Council Directive 93/42/EEC. Medical Device Safety Service. Retrieved January 11, 2010, from http://www.mdss.com/MDEV/93_42_EEC.htm Medical devices – quality management systems – requirements for regulatory purposes. (2007). EN ISO 13485:2003/AC:2007….
…Directive. (1993). Council Directive 93/42/EEC. Medical Device Safety Service. Retrieved January 11, 2010, from http://www.mdss.com/MDEV/93_42_EEC.htm Medical devices – quality management systems – requirements for regulatory purposes. (2007). EN ISO 13485:2003/AC:2007….
…System Regulation. The purchase order should contain critical information such as component cost, quantity, delivery requirements, and applicable quality covenants. Additionally, the component specification, procedures for special processing steps, non-disclosure…
…System Regulation. The purchase order should contain critical information such as component cost, quantity, delivery requirements, and applicable quality covenants. Additionally, the component specification, procedures for special processing steps, non-disclosure…
…with simple calculations. A: Your FEA analysis is probably displaying results as von Mises equivalent stress. In the von Mises failure theory (a.k.a. the Distortion Energy Theory) the tensile, compressive…
…with simple calculations. A: Your FEA analysis is probably displaying results as von Mises equivalent stress. In the von Mises failure theory (a.k.a. the Distortion Energy Theory) the tensile, compressive…
…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…
…for my rules, you could probably come up with dozens of your own. Once again, the approach pursued is the employment of common sense to achieve compliance. Until next time,…
…for my rules, you could probably come up with dozens of your own. Once again, the approach pursued is the employment of common sense to achieve compliance. Until next time,…
…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…
