AAMI's Leading Practice series provides 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 Practice documents are currently available. Order online or by phone at +1-877-249-8226 or +1-240-646-7031.
CAPA: Controlling Nonconforming Product 
This Leading Practice reviews challenges associated with nonconforming product and provides tools and concepts to address nonconforming product, including what standard operating procedures contain, how nonconforming product is segregated, when it is appropriate to use concessions, and what to include in records as proof of documentation and compliance.
Author: Christine Driscoll, director of regulatory affairs at the New York Blood Center
Order Code: LP-CONTROL or LP-CONTROL-PDF
Price: Member $35/ List $70 | Buy Online |
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CAPA: System Implementation and Compliance
This Leading Practice reviews and provides tools and concepts for an effective CAPA system; compares FDS, GHTF, and ISO requirements; provides sample scenarios; and discusses development of standard operating procedures, analysis of data, investigations and actions taken, feedback mechanism, and closed loop for the quality system.
Author: Christine Driscoll, director of regulatory affairs at the New York Blood Center
Order Code: LP-SYSTEM or LP-SYSTEM-PDF
Price: Member $35/ List $70 | Buy Online |
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CAPA Complaints: Practical Approaches to Compliance
This Leading Practice reviews the four frequently cited observations in the Food and Drug Administration’s (FDA) warning letters related to complaint files, and provides tools and examples for an effective complaint handling system.
Author: Lynette Makowski, MAM/QC, BSc, principal consultant, Achieving RA/QA Compliance LLC
Order Code: LP- COMPLNT or LP- COMPLNT-PDF
Price: Member $35/ List $70 | Buy Online
Related Webinar: Leading Practice on Compliance Series: Complaint Files |
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CAPA Verification and Validation: Practical Approaches to Compliance
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, founder of AJW Technology Consultants, Inc
Order Code: LP-CAPA or LP-CAPA-PDF
Price: Member $35/ List $70 | Buy Online
Related Webinar: Leading Practice on Compliance Series: Verifying and Validating CAPAS |
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CAPA Set—Save on the set of four CAPA Leading Practice documents
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Order Code: LP-CAPA-S or LP-CAPA-S-PDF
Price: Member $110
Price: List $220
Buy Online |
Practical Approaches to Compliance: CAPA—Complaints
- System Implementation and Compliance (CAPA)
- CAPA Verification and Validation: Practical Approaches to Compliance
- Controlling Nonconforming Product
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Design History File (DHF)—Tips for Creating a Successful DHF
This Leading Practice provides helpful background and tips on common compliance issues, Design History File development and maintenance, as well as case studies and scenarios to illustrate processes.
Author: Jack Ward, CQM, CSQE, MSCS
Order Code: LP- DH or LP- DH-PDF
Price: Member $35/ List $70 | Buy Online |
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Design Input—Designing the ‘Right’ Device
This Leading Practice provides practical at-a-glance tables, diagrams, and flowcharts to improve design input processes and requirements.
Author: Michael Hoffman, MPH, BSI
Order Code: LP-DI or LP-DI-PDF
Price: Member $35/ List $70 | Buy Online |
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Device Design Set
Order Code: LP-DHI-S or LP-DHI-S-PDF
Price: Member $60
Price: List $125
Buy Online |
- Includes Design History File (DHF)—Tips for Creating a Successful DHF
- Design Input—Designing the 'Right' Device
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Quality Audits:
Strategy for Ensuring Effectiveness and Compliance of Quality System
This Leading Practice 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 |
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Management Responsibility: Connecting Business Acuity and Quality Excellence
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 |
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