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

MDD – Article 19

By Dr. Christopher Joseph Devine

…definitive reason as to why the market withdraw needs to occur. Equally frustrating is when a manufacturer’s devices are blocked from entering market or additional restrictions enacted. The good news

…definitive reason as to why the market withdraw needs to occur. Equally frustrating is when a manufacturer’s devices are blocked from entering market or additional restrictions enacted. The good news

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

MDD – Article 15

By Dr. Christopher Joseph Devine

…of bad news, contrary to popular belief, so Dr. D will commence with the good news first. If a review by the applicable ethics committee, within a Member State(s), views…

…of bad news, contrary to popular belief, so Dr. D will commence with the good news first. If a review by the applicable ethics committee, within a Member State(s), views…

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

MDD – Article 14

By Dr. Christopher Joseph Devine

…Representative. The good news is that device manufacturers are not required to have an EU Authorized Rep in each Member State. One will do just fine. Additionally, the EU Authorized…

…Representative. The good news is that device manufacturers are not required to have an EU Authorized Rep in each Member State. One will do just fine. Additionally, the EU Authorized…

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

Responding to a Warning Letter

By Dr. Christopher Joseph Devine

…significant interruptions in the day-to-day activities of the recipients. What happens after a Warning Letter is received? The good news is that the US Marshalls have not shown up at…

…significant interruptions in the day-to-day activities of the recipients. What happens after a Warning Letter is received? The good news is that the US Marshalls have not shown up at…

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

Responding to a Form 483

By Dr. Christopher Joseph Devine

…704(b) of the Act. The good news is that a formal response to the Agency is not mandated by law. The bad news is that failure to respond to a…

…704(b) of the Act. The good news is that a formal response to the Agency is not mandated by law. The bad news is that failure to respond to a…

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

Records (General Requirements)

By Dr. Christopher Joseph Devine

…number of warning letter and observations before finding an offending device manufacturer. The good news is that it appears, at least on the surface, the majority of device manufacturers understand…

…number of warning letter and observations before finding an offending device manufacturer. The good news is that it appears, at least on the surface, the majority of device manufacturers understand…

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

For Production and Process Controls

By Dr. Christopher Joseph Devine

…ISTA-2A Overview. Retrieved June 24, 2010, from http://www.ista-1a-2a-3a.com/index.html Prop 65 News. (2010, June). Your online guide to California’s unique environmental statute, proposition 65. Retrieved June 21, 2010, from http:// www.prop65news.com/pubs/brochure/madesimple.html…

…ISTA-2A Overview. Retrieved June 24, 2010, from http://www.ista-1a-2a-3a.com/index.html Prop 65 News. (2010, June). Your online guide to California’s unique environmental statute, proposition 65. Retrieved June 21, 2010, from http:// www.prop65news.com/pubs/brochure/madesimple.html…

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