• AAMI/IEC 80001-1 – Sharing the Burden: Collaborating to Keep Networks Safe, Secure and Effective
• AAMI/IEC 80001-1 – Successfully Launching an 80001-1-Based Program
• AAMI TIR45:2012, Guidance on the use of AGILE practices in the development of medical device software NEW
• Achieving Innovation and Breakthrough Usability In Medical Devices: Real-World Processes and Case Studies of Modern Medical User Experience
• ANSI/AAMI/ISO 11663 & 23500, Quality Requirements and Monitoring of Water Treatment and Dialysis Fluid for Hemodialysis and Related Therapies
• Application of Quality Management System Concepts to FDA's Medical Device Data Systems Regulation
• Assurance Case Reports — Infusion Pumps

• Benchmarking and the Value of Certification
• Biological Evaluation of Medical Devices: Application of ANSI/AAMI/ISO 10993 Parts 1 and 17

• Changes to Your Quality Management System: Planning for Unpredictable Consequences
• Communicating Effectively with the C-Suite
• Compatibility of Materials Subject to Sterilization: AAMI TIR 17:2008
• Considerations for Interpretation and Efficient Implementation of ANSI/AAMI/IEC 62304:2006
• Current Insights on the Regulatory Requirement to Validate Production and Quality System Software

• Design of Experiments for Design Control NEW
• Design of Experiments for Process Validation NEW
• Design Transfer: Best Practices for the Successful Transfer of Medical Devices from Research and Development to Manufacturing
• Dialysis Standards: A Detailed Review of ANSI/AAMI RD52, RD62, RD47, and RD61

• Effective Risk-Based CAPA Investigations Based on the New GHTF Guidance Document
• EMC Requirements for Medical Products: A practical application of ANSI/AAMI/IEC 60601-1-2, 3rd Edition
• Enemy at the Gates: Security for Medical Devices
• Ethylene Oxide Residuals — Guidance on the Application of ANSI/AAMI/ISO 10993-7:2008
• Ethylene Oxide Sterilization — Guidance on the Application of ANSI/AAMI/ISO 11135-1

• The FDA’s Unique Device Identification (UDI) Initiative: How Will It Affect Hospitals?

• Guidance on Best Practices and Compliance for Manufacturers: The Nuts and Bolts of Management Review

• Home Hemodialysis, Acute Hemodialysis & Validation: Special Considerations and How They Link to ANSI/AAMI/ISO 23500
• How to Test to IEC 60601-1, 3rd Edition
• Human Factors Approaches to Ensuring Safe Medical Devices
• Human Factors Engineering — Design of Medical Devices, A Review of ANSI/AAMI HE75:2009

• Immediate-Use Steam Sterilization (IUSS)
• Implementing Human Factors Principles and Best Practices in Medical Device Design: Lessons Learned
• Implementing Risk Management into the Design of Electrical Medical Devices
• Introduction to Statistical Methods and Tools for a Quality System
• Introduction to Valid Statistical Techniques for Design Control
• Introduction to Valid Statistical Techniques for Process Validation
• ISO 80369 Small Bore Connectors Standards: Implications for Clinical Users, Manufacturers, and Component Suppliers
• IT Baseline Knowledge for the Healthcare Technology Management Professional

• Joint Commission Update on Preventive Maintenance Strategies

• Keeping Patients Safe: Guidance for Preparation and Quality Management of Fluids for Hemodialysis

• Labeling and Labeling Controls
• Leading Practices on Compliance Series: Complaint Files
• Leading Practices in Compliance Series: Corrective and Preventive Action (CAPA) - Controlling Nonconforming Product NEW
• Leading Practice on Compliance Series: Corrective and Preventive Action (CAPA) - System Implementation and Compliance NEW
• Leading Practice on Compliance Series: Design History File (DHF): Tips for Creating a Successful DHF NEW
• Leading Practice on Compliance Series: Designing the 'Right' Device NEW
• Leading Practices on Compliance Series: Quality Audits
• Leading Practices on Compliance Series: Management Responsibility
• Leading Practices on Compliance Series: Verifying and Validating CAPAs
• Linking Human Factors with FDA's Quality System Regulation: A Critical Component to the Design and Manufacturing Process

• Microbiology for Medical Device Manufacturing and Sterilization

• NFPA 99: What Clinical Engineers and BMETs Need to Know

• Overview of ANSI/AAMI/ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects
• Overview of New Risk Management Standard: ANSI/AAMI/ISO 14971:2007
• Overview on the New AAMI/IEC 80002-1 Medical Device Software Risk Management Technical Report

• Physical aspects of ethylene oxide sterilization: AAMI TIR15:2009
• Planning for a Successful Submission
• Purchasing Controls: Best Practices in a Regulated Environment

• Quality Matters Series: Thwarting Nonconformity: CAPA vs. Preventive Action
• Quality System Concepts Needed for FDA's Medical Device Data Systems Regulation

• Real-World Application of the FDA's Medical Device Data Systems Regulation NEW
• Reprocessing Medical Devices: Current Standards, Guidance, and New Developments in Validation, Cleaning, Disinfecting, and Sterilization Processes
• Rigid Sterilization Containers: Best Practices
• Risk Management and Analysis in a Regulated Environment: Process to Prevent, Mitigate, Control, and Reduce Your Risk

• Solving Supplier Problems While Maintaining Compliance: Real World Examples
• Staffing Metrics: A How to Guide
• Standard Operating Procedures for Quality Systems: Are You Meeting Regulatory Requirements? NEW
• Statistical Tools for CAPA and Complaint Monitoring
• Steam Sterilization Process Failures
• Steam Sterilization in Health Care Facilities: Quality monitoring: A Review of ANSI/AAMI ST79:2010 (including Amendments since 2006)
• Steam Sterilization Process Risk Assessment
• Sterility Assurance Levels for Medical Products Based on ANSI/AAMI ST67:2003 Requirements for Products Labeled 'STERILE'
• Successfully Navigating an FDA Inspection
• Supply Chain Management as an Integral Aspect of Your Quality Management System

• The Importance of Effective Medical Device Reporting
• The Medical Device Data System Rule: Are You in Compliance?
• The New Global Standard for Sterile Medical Device Packaging - ANSI/AAMI/ISO 11607 - Parts 1 and 2
• The Process and Logistics of Internal Quality Auditing in a Regulatory Environment
• The Role of Executive Management in Quality System Compliance

• Ultrapure Dialysate for Hemodialysis and Related Therapies, AAMI TIR43:2011 NEW
• Under the Spotlight: Is Your Facility Prepared for a Sterile Processing Accreditation Survey?
• Understanding and Benefiting from AAMI/IEC 80001-1
• Update on Unique Device Identification (UDI)
• U.S. Medical Device Reporting Requirements

• Validation of Software for Regulated Processes: An Overview of AAMI TIR36:2007

• Water for the Reprocessing of Medical Devices: A Review of Key Aspects of the New AAMI TIR34
• What Has Changed for EO Sterilization? A Comparison of the 1994 and 2007 Versions of ANSI/AAMI/ISO 11135-1

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