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ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

$131.00

The most recent version of International Standardization Organization’s ISO 13485 hasn’t even gone into effect yet and already the Technical Management Board is looking for a rewrite, calling for the standard to be rewritten in a “high-level” format. Find out more here.
November 2, 2018
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Investigator Horror Stories 3: Boozing On The Job? Yup, That Happened – As Have These Other Shocking Tales Of Irregular FDA Inspections

$200.00

Medtech Insight’s Compliance Corner is back for the final installment of the three-part series on Investigator Horror Stories. Tap into the recollections of top industry insiders for a jaw-dropping look at some of the more outrageous tales from the world of compliance.
October 22, 2018
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Thinking about using CMMI? Here are tips from the experts

$200.00

Learn about the voluntary U.S. FDA pilot program that uses Capability Maturity Model Integration (CMMI) from quality,compliance and regulatory officials at three major device firms. Walk through the CMMI process,and discover why it’s nothing like a typical regulatory audit.
June 25, 2018
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Sunshine rules in the EU: Implications of a piecemeal approach

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The EU’s piecemeal approach to transparency makes compliance harder, but this expert advice can smooth the path forward. Learn about implications of these”sunshine”rules in the EU and U.S., how they differ,and what the EU can learn from the U.S.
June 1, 2018
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Bye-Bye QSR? FDA May Swap Its Quality System Regulation For ISO 13485 ‘In The Coming Years,’ Official Says

$131.00

Global regulators are looking to converge–or at least align–various requirements, and the US FDA is no exception. Officials have strongly suggested that the agency will replace its Quality System Regulation with ISO 13485. It won’t be simple. Discover the implications for device makers, and find out what’s involved in making this dramatic change.
May 4, 2018
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Compliance & Risk

Compliance & Risk

ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

Investigator Horror Stories 3: Boozing On The Job? Yup, That Happened – As Have These Other Shocking Tales Of Irregular FDA Inspections

Thinking about using CMMI? Here are tips from the experts

Sunshine rules in the EU: Implications of a piecemeal approach

Bye-Bye QSR? FDA May Swap Its Quality System Regulation For ISO 13485 ‘In The Coming Years,’ Official Says