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ANSI/AAMI ES60601-1:2005/(R)2012, (IEC 60601-1:2005, MOD)

This standard incorporates Amendment 1 with changes highlighted in the text.
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AAMI HIT1000-1(PS):2018 (PDF)

Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements
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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 TIR38:2019

Medical device safety assurance case guidance
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$133.00
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$236.00
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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/IEC TIR61289:2011

High frequency surgical equipment - Operation and maintenance.
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$90.00
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$157.00
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AAMI/IEC TIR80001-2-7:2014

Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
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$155.00
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AAMI/ISO TIR16775:2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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ANSI/AAMI 11663:2014

Quality of dialysis fluid for hemodialysis and related therapies.
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$72.00
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ANSI/AAMI 13958:2014

Concentrates for hemodialysis and related therapies.
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$90.00
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ANSI/AAMI 13959:2014

Water for hemodialysis and related therapies.
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$72.00
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ANSI/AAMI AT6:2013

Autologous transfusion devices.
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$72.00
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ANSI/AAMI BF64:2012

Leukocyte reduction filters.
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$72.00
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ANSI/AAMI BF7:2012

Blood transfusion micro-filters.
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$72.00
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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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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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ANSI/AAMI EC12:2000/(R)2015

Disposable ECG electrodes
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$72.00
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ANSI/AAMI ES60601-1:2005/(R)2012 (Travel Edition)

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$604.00
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ANSI/AAMI ES60601-1:2005/A1:2012

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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$165.00
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