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AAMI TIR12:2010

Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
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AAMI TIR12:2010 Red-line (PDF)

Includes Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers and red-line format of document showing changes between the current and 2004 version in red and strikethrough, PDF format.

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$140.00
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$237.00
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AAMI TIR18:2010

Guidance on electromagnetic compatibility of medical devices in healthcare facilities
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$133.00
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AAMI TIR36:2007 (PDF)

Validation of software for regulated processes
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$155.00
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AAMI TIR49:2013

Design of training and instructional materials for medical devices used in non-clinical environments
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$111.00
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$194.00
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$194.00
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AAMI TIR65:2015

Sustainability of medical devices-Elements of a responsible product life cycle
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$126.00
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$221.00
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$221.00
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AAMI/CQT Solutions Design Control Requirements - Integrating The Quality System Regulation and ANSI AAMI ISO 13485

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This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience. 

An optional exam is available online for 2 weeks following the end of the program.

 

Program Outline

 


DAY 1 | 8 AM-5 PM
Introduction to Design Control Scope and Applicability
Design Development and Planning
Design Input 

Risk Management
Design Output


DAY 2 | 8 AM-5 PM
Design Review
Design Verification
Design Validation
Software Validation


DAY 3 | 8 AM-5 PM
Design Changes 
Design History File
FDA Inspectional Approach
MDSAP





 

 

Program Objective

Upon completing this course, participants will be equipped with the information to able to evaluate the degree of compliance of a design control system, including identification of noncompliance issues, and be prepared to implement the improvements needed to meet requirements.


This highly interactive course engages the learner with an in-depth discussion of industry best practices to learn how industry leaders address design control challenges. Exercises are designed to build a solid understanding of developing and applying design control requirements. Attendees will participate in structured discussions with their peers to develop solutions to solve current issues.

Examples of design control tools, templates, and practices, in use by medical device companies, stimulate discussion and provide a practical resource for future reference. Case studies and situation analyses are used throughout the program to help participants analyze potential areas of noncompliance, identify improvements, and evaluate the various methods of managing a design control program.

Course content is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturing companies, FDA, and industry consultants.

 

Target Audience

Instruction is targeted to professionals involved in meeting design control requirements such as those in regulatory affairs, quality assurance, design engineering, manufacturing, operations, and members of research and development or new product development teams.

 

Materials

Fee includes a printed copy of the textbook, The Quality System Compendium, and electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, additional references, and access to the online exam.




Registration Fees:

  • Standard Ticket: €2495
  • 5+ Bookings: €2369
  • 10+ Bookings: €2245


Start Date:
Monday, September 30, 2019
End Date:
Wednesday, October 02, 2019
Address:
Royal Marine Hotel
DUBLIN
IRELAND
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AAMI/ISO TIR17137:2014 (PDF)

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
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$90.00
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$157.00
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AAMI/ISO TIR22442-4:2011/(R)2016

Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes.
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$90.00
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$157.00
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AAMI/ISO TIR23810:2012/(R)2015

Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup.
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$111.00
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$194.00
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AAMI/ISO TIR80002-2:2017 (PDF)

Medical device software—Part 2: Validation of software for medical device quality systems
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$155.00
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AAMI's Leadership Development Guide (PDF)

A Resource for Healthcare Technology Management Professionals
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$0.00
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ANSI/AAMI AT6:2013

Autologous transfusion devices.
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$72.00
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$127.00
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ANSI/AAMI BP22:1994/(R)2016

Blood Pressure Transducers
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$72.00
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$127.00
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$127.00
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ANSI/AAMI CI86:2017 (PDF)

Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
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$155.00
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$274.00
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ANSI/AAMI HE75:2009/(R)2018 (PDF)

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$235.00
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$415.00
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$415.00
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ANSI/AAMI ST40:2004/(R)2018 (PDF)

Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities
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$126.00
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$221.00
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ANSI/AAMI ST58:2013/(R)2018 (PDF)

Chemical sterilization and high-level disinfection in health care facilities
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$155.00
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$274.00
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ANSI/AAMI ST65:2008/(R)2018 (PDF)

Processing of reusable surgical textiles for use in health care facilities
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$133.00
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$236.00
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$236.00
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