AAMI's Leading Practices provide concise and practical information on a host of topics important to professionals in healthcare technology.
This series provides insights from the best and the brightest in the field on topics affecting manufacturers, regulatory affairs professionals, clinicians, clinical engineers, and biomedical equipment technicians. Designed to give quick, practical advice, these leading practices include graphics, charts, and forms that illustrate each topic.
The following leading practices are currently available. Additional Leading Practices will be published throughout the year.
Quality Audits:
Strategy for Ensuring Effectiveness and Compliance of Quality System |
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This Leading Practices document discusses the need for manufacturers to conduct regular quality audits led by individuals
not directly responsible for the matters being audited, with management review of audit results.
Author: John Gagliardi, president of Midwest Process Innovation, LLC
Order Code: LP-QA or LP-QA-PDF
Price: Member $35/ List $70
Buy Online: 
Related Webinar: Leading
Practices on Compliance Series: Quality Audits |
Management Responsibility: Connecting Business Acuity and Quality Excellence |
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Designed to highlight for medical device firms the role of top management in ensuring effective
and compliant operation of the Quality Management System.
Author: John Gagliardi, president of Midwest Process Innovation, LLC
Order Code: LP-MR or LP-MR-PDF
Price: Member $35/ List $70
Buy Online:
Related Webinar: Leading Practices on Compliance Series: Management Responsibility |
CAPA Verification and Validation:Practical Approaches to Compliance |
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This Leading Practice is designed to help medical device firms better understand, implement, and comply with the
Corrective and Preventive Action (CAPA) section of the Quality System Regulation (21 CFR 820.100).
Author: Art Ward, PhD, MBA, BSEE, the founder of AJW Technology Consultants, Inc
Order Code: LP-CAPA or LP-CAPA-PDF
Price: Member $35/ List $70
Buy Online:
Related Webinar: Leading Practices on Compliance Series: Verifying and Validating CAPAS |
Or order by phone at +1-877-249-8226 or +1-240-646-7031.
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