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A Guide for Medical Device Manufacturers: Understanding and Applying the FDA Processes, Terminology, and Informational Databases for U.S. Medical Device Classification (Webinar On Demand)

This webinar provides a comprehensive overview of the FDA processes, terminology, and informational databases established for U.S. medical device classification.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


AAMI TIR48:2015

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
AAMI Member:
$146.00
List Price:
$258.00
Available for Immediate Download
↑/↓ Full Details


An FMEA Trifecta: sFMEA, dFMEA, & pFMEA (Webinar On Demand)

If you perform a System-Level Failure Mode & Effects Analysis (sFMEA), a Design FMEA (dFMEA), and a Process FMEA (pFMEA), then they can be linked to become a robust risk-analysis tool set. Linking these three tools can be considered a trifecta* • a safe bet on risk mitigation. A successful trifecta is great cause for celebration • risk and product managers can finally rest easy!
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


ANSI/AAMI/ISO 13485:2016

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
AAMI Member:
$131.00
List Price:
$222.00
↑/↓ Full Details


ANSI/AAMI/ISO 15225:2016

Medical devices - Quality management - Medical device nomenclature data structure
AAMI Member:
$84.00
List Price:
$148.00
Available for Immediate Download
↑/↓ Full Details


ANSI/AAMI/ISO TIR14969:2004

Quality management systems - Medical devices - Guidance on the application of ISO 13485:2003
AAMI Member:
$125.00
List Price:
$222.00
Available for Immediate Download
↑/↓ Full Details


Assurance Cases for Medical Devices: Annual Updates from FDA and Industry Practitioners (Webinar On Demand)

Join a group of industry experts and FDA leaders as they explore assurance cases. Attendees will hear from FDA representatives in charge of reviewing assurance cases about common issues seen in submissions and the FDA's expectations. Attendees will also hear from industry experts about assurance case practices and emerging applications.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


Combination Products: Understand and Implement the Requirements (Webinar On Demand)

The goals of this webinar are to: explain and summarize the regulatory requirements for combination products, describe the broad range of products considered combination products, identify gaps in the existing quality system to meet 21 CFR 4 requirements, apply the FDA "streamlined approach" to the existing approach in your company, and bridge the gap between requirements coming from 21 CFR 210 & 211 versus a 21 CFR 820 based quality system.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


Communications for Quality System Managers On-Demand Course

This course helps you explain the meaning and importance of communication for quality system managers, implement general tools and techniques you can use to achieve successful communication, determine how to communicate effectively with various audiences, and communicate with documentation.
AAMI Member:
$199.00
List Price:
$250.00
Available for Immediate Download
↑/↓ Full Details


Conducting Quality Audits for Regulated IT Systems (Webinar On Demand)

This interactive four-part webinar series provides an overview of the methods and techniques for performing a quality audit of regulated IT systems -- those IT systems used in a company’s quality management system for development, manufacture, and support of medical device products.
AAMI Member:
$399.00
List Price:
$549.00
Available for Immediate Download
↑/↓ Full Details


Control Charts for Visualizing and Detecting Trends (Webinar On Demand)

Have you ever accused your associates of “pinging” • that is, over-reacting to the slightest changes in production, CAPA, complaint monitoring, or servicing? Or worse yet, have folks in your organization over-looked obvious trends in problems? This webinar will provide a valid statistical procedure that is so simple, you won’t even know that you are applying statistics all the time. Control charts are highly graphical tool applied in most world-class organizations.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


Current Issues in Medical Device Risk Management: FDA and EU Issues (Webinar On Demand)

With the increasing complexity of medical devices, device product recalls, and the growth of adverse events, manufacturers are facing the ever-increasing challenge of making sure that a stringent process is in place for medical device risk assessment. This webinar will review the risk management principles shown in ANSI/AAMI/ISO 14971 standard. Register for this webinar and learn about the FDA risk management expectations for product submissions, review the FDA indicators of risk management shortcomings, and compare the FDA risk requirements to Europe’s expectations in the medical product directives. The information presented in this webinar will help you recognize the value of underused risk analysis tools.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


Design Control Guidance for Medical Device Manufacturers

FDA’s guidance on how to comply with the design control requirements of the Quality System regulation.
AAMI Member:
$22.00
List Price:
$37.00
↑/↓ Full Details


Documents and Records Management for Medical Devices (On-Demand Course)

This online program provides participants with the skills and tools needed for quality improvement and compliance within their organization as related to the handling of documents and records. Course content utilizes real-life scenarios with a variety of situations and case studies for analysis toward practical resolutions.
AAMI Member:
$495.00
List Price:
$625.00
Available for Immediate Download
↑/↓ Full Details


EN ISO14971:2012 and Its Impact on You (Webinar On Demand)

The goal of this webinar is to familiarize attendees with the impact of the new harmonized standard, EN ISO 14971: 2012, Medical devices - Application of risk management to medical devices. This standard contains annexes that modify the way that ISO 14971 can be used to satisfy the EU essential requirements. The changes that you may need to make include elimination of the use to the ALARP principle and the need to do a risk/benefit assessment of both overall and individual residual risks. If your firm markets products in the EU, this webinar will provide information to help your firm comply. These changes are important because they can affect your entire approach to risk management, both premarket and postmarket.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


FDA Compliance Overview: What Else Is There (Besides 21 CFR 820)? (Webinar On Demand)

This webinar provides a summary of some of the main FDA Regulatory Compliance Topics other than the Quality system Regulation (21 CFR 820). We will provide an overview of some of these regulations to offer a broad understanding of FDA requirements outside the QS Reg.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


FDA Final Guidance for Infusion Pumps: Total Product Life Cycle and Safety Assurance Cases (Webinar on Demand)

The FDA recently released the final guidance for Infusion Pumps Total Product Life Cycle. With the final guidance, FDA lays out further details and clarification on safety assurance cases compared to the April 2010 draft guidance.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


FDA's Guide to Inspections of Quality Systems

A handbook for device manufacturers to prepare for the FDA's inspection process, Quality Systems Inspections Technique (QSIT). Featuring "must know" flow charts and checklists.
AAMI Member:
$35.00
List Price:
$58.00
Available for Immediate Download
↑/↓ Full Details


FMEA Without Tears (Webinar On Demand)

The goal of this webinar is to facilitate the successful application of FMEA as a valuable risk analysis and risk management tool. This webinar will give you an opportunity to hear directly from an industry expert who has facilitated the application of FMEA across a wide variety of organizations. He successfully leads teams tasked with risk analysis and risk management through a mentoring and “divide-and-conquer” approach. In most cases, an FMEA exercise lasts 1-4 hours, depending on the complexity and risk involved. In one case, a thorough FMEA for a complex, Class 3 medical device was completed, documented, and submitted in only three days. In another case, a risk analysis was conducted in 30 minutes using a simplified FMEA! But the key measure of success is that all team members feel that their effort yielded credible and actionable results.
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details


Getting to the Root: Investigation Methods and Their Applications (Webinar on Demand)

There are a multitude of investigation methods that can be applied to solving an issue, some allowing multiple solutions and some providing drill down to the final root cause. This program will focus on two specific processes: the Ishikawa diagram method (a macro problem-solving tool) and the 5 Whys technique (a micro-investigation tool).
AAMI Member:
$315.00
List Price:
$415.00
Available for Immediate Download
↑/↓ Full Details