Quality System Collection
What it is: Updated in 2010 to include HE75 and 62366, this CD includes every AAMI standard for the quality system, medical device software, and human factors; important government guidance documents from the FDA and GHTF; and quick links to government resources such as the Recall, PMA, Recognized Standards, and MDR databases.
Who it is for: Medical device professionals in U.S. and international markets looking for a convenient, single source for key standards, guidance documents, and expert analysis and advice on device development issues such as regulatory processes, risk management, process validation, product introduction, complaint handling, design input, software testing, and more.
What it contains: More than 60 documents including AAMI/American National Standards (many of which are identical to their ISO counterpart standards) and technical information reports, FDA and GHTF Guidance, and articles from industry experts. See lists below.
Order Information:
- Order Code: AQS-CD
- List Price: $640
- Member Price: $430
- Buy online now!! OR call +1 877-249-8226
AAMI/American National Standards and Technical Information Reports
- Medical devices--Quality management systems--Requirements for regulatory purposes (ANSI/AAMI/ISO 13485:2003)
- Medical devices--Application of risk management to medical devices (ANSI/AAMI/ISO 14971:2007)
- Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices (ANSI/AAMI/ISO TIR16142:2005)
- Medical devices--Quality management systems--Guidance on the application of ISO 13485:2003 (ANSI/AAMI/ISO TIR14969:2004
- Medical device software-Software life cycle processes (ANSI/AAMI/IEC 62304:2006)
- Medical device software risk management (AAMI TIR32:2004)
- Validation of software for regulated processes (AAMI TIR36:2007)
- Medical devices - Application of usability engineering to medical devices (ANSI/AAMI/IEC 62366:2007)
- Human factors engineering - Design of medical devices (AAMI HE75:2009)
FDA and GHTF Guidance including:
- Quality System regulation
- FDA's Guide to Inspections of Quality Systems
- Medical Device Quality Systems Manual: A Small Entity Compliance Guide
- Final Design Control Report and Guidance
- Quality Management Systems--Process Validation Guidance
- Do It By Design: An Introduction to Human Factors in Medical Devices
- Deciding When to Submit a 510(k) for a Change to an Existing Wireless Telemetry Medical Device: Final Guidance for FDA Reviewers and Industry
- Human Factors Implications of the New GMP Rule
- Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
- Electronic Records; Electronic Signatures; Final Rule
- Part 11, Electronic Records; Electronic Signatures-Scope and Application
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff
- Guidance for Industry, FDA Reviewers, and Compliance on Off-the-Shelf Software Use in Medical Devices
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Guidance for Industry on Computerized Systems Used in Clinical Trials
- Glossary of Computerized System and Software Development Terminology
And articles from industry experts including:
- A Closer Look at Outsourcing and the Quality System
- Management Responsibility Enables Success
- Effective Training Yields Learning and Growth
- Clearly Defined Design Input is Key to Product Development
- An Engineer’s Role in Preparing for FDA Inspections
- Uses and Misuses of Probability in Medical Device Risk Management
- The Critical Path to New Medical Devices
- Combination Products and the Role of Medical Device Firms
- How to Kick-Start Your CAPA Process
- The Importance and Benefits of Effective Medical Device Complaint Handling
- The Future of Biomedical Software: How Higher Standards for Privacy, Security, and Quality Will Change the Industry
- Process Validation: Achieving the Operational Qualification Phase
- Altering the Genetic Code of Management Review
- Understanding CAPA Requirements in a Software Context
- Creating a Value-Added Risk Management Process
- Improving Product Introduction Through Effective Design Reviews
- Conducting the Right Investigation
- Risk Management--A Global Requirement
- Software Testing--How Much is Enough?
- Process Validation: Removing the Magic, Mystery, and Mayhem