Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD–Article 10

By Dr. Christopher Joseph Devine

…on a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm…

…on a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD–Article 8

By Dr. Christopher Joseph Devine

…on a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm…

…on a medical devices vigilance system. European Commission DG Enterprise and Industry. Retrieved February 26, 2011, from www.gtlaw.com/portalresource/lookup/wosid/contentpilot Vigilance Reports. (2011, February). Europa.en Website. Retrieved February 26, 2011, from http://ec.europa.eu/consumers/sectors/medical-devices/documents/vigilance-reports/index_en.htm…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD–Article 5

By Dr. Christopher Joseph Devine

…exposed to Dr. D’s diatribes in regards to compliance with harmonized standards. Yes, compliance to the standards is not mandated by law; however, it is important that harmonized standards appropriate…

…exposed to Dr. D’s diatribes in regards to compliance with harmonized standards. Yes, compliance to the standards is not mandated by law; however, it is important that harmonized standards appropriate…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MDD – Definitions and Scope

By Dr. Christopher Joseph Devine

…you can takeaway a better understanding of the regulatory requirements and the potential compliance pitfalls associated with complying with the Directive. Article 1 of the scope is appropriately entitled “Definitions,…

…you can takeaway a better understanding of the regulatory requirements and the potential compliance pitfalls associated with complying with the Directive. Article 1 of the scope is appropriately entitled “Definitions,…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The Medical Device Directive

By Dr. Christopher Joseph Devine

…93/42/EEC – introduction. (2010). Medical Device Certification. Retrieved December 22, 2010, from http://www.mdc-ce.de/cert_md1.htm Schnoll, L. (1997, September). The CE Mark: Medical Device Directive. Retrieved December 22. 2010, from http://www.qualitydigest.com  …

…93/42/EEC – introduction. (2010). Medical Device Certification. Retrieved December 22, 2010, from http://www.mdc-ce.de/cert_md1.htm Schnoll, L. (1997, September). The CE Mark: Medical Device Directive. Retrieved December 22. 2010, from http://www.qualitydigest.com  …

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Consent Decree

By Dr. Christopher Joseph Devine

…As Dr. D has repeatedly stated, failure to comply is not an option. Compliance to the Act and the QSR is mandated by law and guess what? It is FDA…

…As Dr. D has repeatedly stated, failure to comply is not an option. Compliance to the Act and the QSR is mandated by law and guess what? It is FDA…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Responding to a Warning Letter

By Dr. Christopher Joseph Devine

…doctoral dissertation. Northcentral University. Prescott Valley, AZ. Garvey, J. (2010, January). FDA form 483 & warning letter response & planning. Compliance Architects Website. Retrieved December 8, 2010, from http://www.compliancearchitects.com Godshalk,…

…doctoral dissertation. Northcentral University. Prescott Valley, AZ. Garvey, J. (2010, January). FDA form 483 & warning letter response & planning. Compliance Architects Website. Retrieved December 8, 2010, from http://www.compliancearchitects.com Godshalk,…

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Responding to a Form 483

By Dr. Christopher Joseph Devine

…The definition of FDA 483. Retrieved November 27, 2010, from http://www.ehow.com Taylor, N. (2009, February). Ignore a form 483? Not wise say FDA. Retrieved November 27, 2010, from http://www.in-pharmatechnologist.com  …

…The definition of FDA 483. Retrieved November 27, 2010, from http://www.ehow.com Taylor, N. (2009, February). Ignore a form 483? Not wise say FDA. Retrieved November 27, 2010, from http://www.in-pharmatechnologist.com  …

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Statistical Techniques

By Dr. Christopher Joseph Devine

…Drug & Cosmetic Division ASQC, 103. Retrieved March 23, 2007, from http://www.variation.com/techlib/as-1.html Taylor, W. (1996). Selecting statistically valid sampling plans. Quality Engineering 10(2). Retrieved March 5, 2007, from http://www.variation.com/techlib/as-7.html  …

…Drug & Cosmetic Division ASQC, 103. Retrieved March 23, 2007, from http://www.variation.com/techlib/as-1.html Taylor, W. (1996). Selecting statistically valid sampling plans. Quality Engineering 10(2). Retrieved March 5, 2007, from http://www.variation.com/techlib/as-7.html  …

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Servicing

By Dr. Christopher Joseph Devine

…Dr. D strongly believes that there are no such animals as minimum-level of compliance or maximum-level of compliance. There is only compliance, period! Establish and maintain instructions and procedures The…

…Dr. D strongly believes that there are no such animals as minimum-level of compliance or maximum-level of compliance. There is only compliance, period! Establish and maintain instructions and procedures The…

Continue reading