Newsletter | August 31, 2019

08.31.19 -- August's Most Popular Articles & Solutions

Top Featured Editorial
What Is The Current State Of BREXIT, And What Happens Next?
By Zaid Al-Nassir, Decision Resources Group (DRG)

The United Kingdom’s plan to leave the European Union now has PM Boris Johnson at the helm and (seemingly) a hard deadline of Oct. 31, 2019. Zaid Al-Nassir's breakdown for medtech leaders has been updated to include events taking place through Aug. 1, 2019.

How To Prepare For An FDA Inspection
By Mark Durivage, Quality Systems Compliance LLC

An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.

MDSAP — History And Advantages
By Edwin Bills, consultant

The Medical Device Single Audit Program (MDSAP) has worked out its kinks and is poised for exponential growth, but it may be a while before the initiative makes headway in the EU and China.

Top Industry Insights
How To Recognize Effective CAPAs And A Culture Of Quality
Article | Flexan

When OEMs choose an outsourcing partner, they need to trust the effectiveness of the supplier’s CAPA program, and they need to trust that the supplier’s culture sustains quality each and every day, for every device.

Medical Device Manufacturer Improves Product Quality Control
Case Study | Dassault Systemes Americas

Osstem Implant adopted an integrated business framework that helps it eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.

Strategic Prototyping For Human-Factors Engineering
Article | By Andrew DiMeo, Trig

Human-factors engineering (HFE) is gaining increasing attention, especially in the context of medical device product development. As technologies evolve, therapies advance, and devices become more complex, so does the role of HFE increase in priority.

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