QA/RA Consulting, Auditing & Training
QMSR Is Taking the Spotlight, But MDSAP Still Deserves Attention Why does MDSAP still deserve attention? Because “we’ve aligned to QMSR” and “we’re ready for MDSAP” are not the same thing. At some point in a lot of QMSR transition efforts, things start to feel pretty good. Processes have been updated. Risk-based thinking is getting […]
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How FDA Distinguishes Between Medical Device Servicing and Remanufacturing Many medical devices eventually require preventative maintenance or repairs, and this vital service can be performed by a manufacturer, health institution, independent servicing organization (ISO), or third-party service company. In a 2018 report, FDA noted that their analysis of comments, complaints, and adverse events revealed that […]
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The US FDA Case for Quality (CfQ): What It Is and Why You Should Care For decades, the medical device industry has largely viewed the US Quality System Regulation (QSR) as a regulatory speedbump on the path to market access. Despite the regulation’s name, product quality has typically taken a back seat to regulatory compliance […]
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How to Conduct an Internal Audit Opening Meeting: Tips from Training 130,000+ Medical Device Auditors For a new auditor, the opening meeting is critical. How you conduct yourself, and how organized you are, establishes your credibility and sets the tone for the audit to follow. If you appear unsure and unorganized, your audit will not […]
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The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection Unlike Regulatory Authorities in most other countries, the US Food and Drug Administration (FDA) relies on random inspections to keep medical device manufacturers honest. Random audits can occur at any time, and that means manufacturers must always remain in compliance with the FDA […]
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Listen and Learn: Develop These Soft Skills and Become a Better Medical Device Auditor You├óΓé¼Γäóve heard it many times before: ├óΓé¼┼ôGreat├é┬á(insert any profession here)├é┬áare made, not born.├óΓé¼┬¥ The saying is especially applicable to auditors.├é┬áTruly effective auditors seem to have an ability to effortlessly extract nuggets of good information from their interviewees. They know how to […]
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