This new collection is your one-stop resource for 80001 and Medical Device Data System (MDDS) guidance. Searchable and easy to use, it includes 11 standards, 5 webinars, and other key resources.

Standards

ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
ANSI/AAMI/IEC TIR80001-2-1:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples
ANSI/AAMI/IEC TIR80001-2-2:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
ANSI/AAMI/IEC TIR80001-2-3:2012, Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
ANSI/AAMI/IEC TIR80001-2-4:2012, Application of risk management for IT-networks incorporating medical devices -- Part 2-4: General implementation guidance for healthcare delivery organizations
ANSI/AAMI/ISO 14971:2007/(R)2010, Medical devices - Application of risk management to medical devices
ANSI/AAMI/ISO TIR24971:2013, Medical devices - Guidance on the application of ISO 14971
ANSI/AAMI/IEC TIR80002-1:2009, Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
AAMI TIR32:2004, Medical device software risk management
ANSI/AAMI/IEC 62304:2006, Medical device software - Software life cycle processes
ANSI/AAMI SW87:2012, Application of Quality Management System concepts to Medical Device Data Systems (MDDS)

Webinars

ANSI/AAMI/IEC 80001-1:2010 Series (Archived Webinars) These webinars address the requirements for collaboration in 80001-1: how they should be implemented, how to voluntarily get the cooperation that is needed, and what cooperation will look like.

AAMI/IEC 80001-1 ' Successfully Launching an 80001-1-Based Program
AAMI/IEC 80001-1 ' Sharing the Burden: Collaborating to Keep Networks Safe, Secure and Effective
Medical Device Data Systems Series (Archived Webinars)

These programs review the regulatory requirements, provide updates from the FDA on the MDDS initiative, and offer case studies of MDDS compliance.

Quality System Concepts Needed for FDA's Medical Device Data Systems Regulation
Application of Quality Management System Concepts to FDA's MDDS Regulation
Real-World Application of the FDA's Medical Device Data Systems Regulation