January 2014

For Medical Device Companies

FDA Inspections: Ensure Quality and Compliance

by Michael R. Hamrell, MORIAH Consultants

You have just been informed by your boss that the FDA is coming to conduct an inspection of a clinical study recently completed at your facility. Does this raise your anxiety level and that of your staff to near panic levels? With proper planning and preparation, a FDA inspection does not have to be a nightmare experience.

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Building a Quality Plan for EN ISO 14971:2012

by: Robert Packard, MedicalDeviceAcademy.com

Rob Packard reviews the seven deviations in Annex ZA, ZB, and ZC with respect to the intent of the Medical Devices Directorate (MDD), the AIMD, and the In Vitro Diagnostic Directive(IVDD).

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10 Guidelines for Writing Superior SOPs

by Robyn Barnes, MasterControl Inc

Will you be prepared when tasked to write a standard operating procedure (SOP)? Writing SOPs--- shorthand for a written document that helps ensure accuracy and repeatability when executing a task---is an integral part of assembling a successful quality system. When poorly written, they are of limited value. Using the following 10 guidelines, you can create a successful SOP document.

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