“Scott is very detailed oriented Quality Professional Who produce results very quickly and has a Very pleasant personality”
About
Strategic results-oriented regulatory affairs and quality assurance professional with…
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Super proud to be recognized by Inc.com as #11 fastest growing private company in the Northeast! Thank you to all of our #medtech customers and to…
Super proud to be recognized by Inc.com as #11 fastest growing private company in the Northeast! Thank you to all of our #medtech customers and to…
Liked by Scott Wright, CQA
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Excited to share some BIG Rimsys Regulatory Management Software news today - we’ve closed a $16M Series A led by Bessemer Venture Partners!!! 🔥🚀🎉…
Excited to share some BIG Rimsys Regulatory Management Software news today - we’ve closed a $16M Series A led by Bessemer Venture Partners!!! 🔥🚀🎉…
Liked by Scott Wright, CQA
Experience
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Education
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CCAC
Licenses & Certifications
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CMDCAS
Health Canada Medical Device Bureau
Issued -
JPAL
BSI
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60601 Concepts
BSI
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BSI Client Assessments
BSI
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ISO Lead Auditor
BSI
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Medical Device Directive (MDD)
BSI
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Certified Quality Auditor
ASQ
Issued ExpiresCredential ID 40979
Publications
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Most Common Breakdowns in Design Controls that Frequently Result in the Issuance of FDA Citations (Form 483)
Knowing what to expect before an FDA design control inspection can alleviate much concern. When assessed by main section number, Design Controls (21 CFR 820.30) is the most frequently referenced deficiency resulting in 483s issued to medical device manufacturers, accounting for 13% of 483s issued in FY2012.
This paper aims to empower medical device manufacturers with the necessary information for understanding the trends in FDA 483 citations and best practices needed to establish and…Knowing what to expect before an FDA design control inspection can alleviate much concern. When assessed by main section number, Design Controls (21 CFR 820.30) is the most frequently referenced deficiency resulting in 483s issued to medical device manufacturers, accounting for 13% of 483s issued in FY2012.
This paper aims to empower medical device manufacturers with the necessary information for understanding the trends in FDA 483 citations and best practices needed to establish and maintain a compliant design control system. As one paper in a series analyzing 483 citations and design control trends, this paper focuses specifically on trends related to the first two elements of a robust design control system: procedures and planning.
http://hubs.ly/y0Tk8J0Other authors -
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