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

You Have Just Been Disqualified, Ouch!

By Dr. Christopher Joseph Devine

…guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.  FDA’s enforcement page. (2014, March). FDA.gov Website. Retrieved March 31, 2014, from http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm. …

…guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.  FDA’s enforcement page. (2014, March). FDA.gov Website. Retrieved March 31, 2014, from http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm. …

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Purchasing Controls and Supplier Management

By Michael Biros

…is complete and the records should be adequately maintained and stored. This process not only helps ensure regulatory compliance, but also improves business efficiency. Quality Management System Purchasing has a…

…is complete and the records should be adequately maintained and stored. This process not only helps ensure regulatory compliance, but also improves business efficiency. Quality Management System Purchasing has a…

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

Control Your Suppliers or Else!

By Dr. Christopher Joseph Devine

…contractors, and consultants. Your firm failed to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and document…

…contractors, and consultants. Your firm failed to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and document…

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Medical Device Supplier Certification: the Rx-360 Approach

By MedTech Intelligence Staff

…device space to actively monitor their supply chain and keep abreast of changes in the device regulatory scene, and kept coming back to Rx-360, because “they have the infrastructure to…

…device space to actively monitor their supply chain and keep abreast of changes in the device regulatory scene, and kept coming back to Rx-360, because “they have the infrastructure to…

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

The MDD – Cha-Cha-Cha-Changes!

By Dr. Christopher Joseph Devine

…devices; Creation of a Medical Device Coordination Group (MDCG) comprised of members of Competent Authorities; A review of Class III Device applications (design dossiers) by the MDCG; A requirement for

…devices; Creation of a Medical Device Coordination Group (MDCG) comprised of members of Competent Authorities; A review of Class III Device applications (design dossiers) by the MDCG; A requirement for

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

Finally, eMDRs

By Dr. Christopher Joseph Devine

…to comply with the electronic filing requirement come August 2015. However, user facilities can choose to use the electronic filing approach or continue to send paper copies. Submission basics via…

…to comply with the electronic filing requirement come August 2015. However, user facilities can choose to use the electronic filing approach or continue to send paper copies. Submission basics via…

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

Contract Manufacturers – Choose Wisely

By Dr. Christopher Joseph Devine

…true for the growing field of virtual device manufacturers popping up not only in the United States but around the globe. That being said, the fundamental questions that need to…

…true for the growing field of virtual device manufacturers popping up not only in the United States but around the globe. That being said, the fundamental questions that need to…

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MEDdesign

5 Top Annual Plan Medical Device Design and Development Process Improvements

By Scott Phillips

new touchscreen to replace a tried and true tactile operator interface. Unfortunately, operators reverted to the old model despite other disadvantages because they hated interacting with the new, “advanced” touchscreen….

new touchscreen to replace a tried and true tactile operator interface. Unfortunately, operators reverted to the old model despite other disadvantages because they hated interacting with the new, “advanced” touchscreen….

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Devine Guidance

What Part of Death or Serious Injury is Not Being Understood?

By Dr. Christopher Joseph Devine

…required time frame. These examples are not all-inclusive and there may be additional reportable events that your firm failed to report. For example: Complaints (b)(4) describe a malfunction of the…

…required time frame. These examples are not all-inclusive and there may be additional reportable events that your firm failed to report. For example: Complaints (b)(4) describe a malfunction of the…

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