The main goal of this research collaboration is to develop a fully validated best practice medical device software and cybersecurity testing framework for the development of medical device products. The RSRC will work closely with the Aerogen team to investigate the specific challenges posed by their existing software development environment in relation to the development of products containing evolving technology and software that are now subject to regulation within the medical device domain. This will form the basis for the development and validation of a best practice Framework (including integrating usability and agile practices etc.) for medical device software processes (including development of wireless medical devices). This framework will then be introduced into the medical device software development lifecycle within Aerogen. In addition, this research will also focus on the Development and Validation of a medical device security feature testing framework for ensuring that effective security testing processes in line with the FDA Cybersecurity Guidance documentation. This framework will be introduced into a new product lifecycle within Aerogen that will assist their products to comply with the latest medical device cybersecurity regulations. The research conducted on medical device software processes and cybersecurity processes will then be combined into a single integrated framework. The efficiency and performance of the integrated framework will then be improved through trialling and tailoring within Aerogen.

For further information on Aerogen, please visit http://www.aerogen.com/

The main goal of this research is the development and validation of a Medical Device Software Defect Taxonomy in association with the AAMI. The RSRC will work closely with the AAMI team to investigate the use of defect taxonomies in other industries and the benefits and challenges associated with their use. The RSRC will also work closely with AAMI in validating the defect taxonomy which is currently being developed by AAMI which will be published as an AAMI standard under the title of “SW91, Classification of Defects in Health Software”. The RSRC will provide assistance in the validation and development of the taxonomy. This will include mapping the developed taxonomy against various existing defect taxonomies and defect data to ensure that all relevant defect categories have been included in the taxonomy which is under development. The research will also involve interaction with other partners in the medical device software development industry participating in the Lero project in order to get feedback and further validate the taxonomy

For further information on AAMI and the work being carried out as part of the collaboration, please click on the links below:

http://www.aami.org

http://www.aami.org/productspublications/articledetail.aspx?ItemNumber=3641

The main aim is to develop a fully validated best practice mobile medical software and mobile medical cybersecurity storage and retrieval framework for the development of mobile medical applications. The RSRC will work closely with the BlueBridge Technologies team to investigate the specific challenges posed by their existing software development environment in relation to the development of software applications that are now subject to regulation within the medical device domain. This will form the basis of the development and validation of a best practice framework (including integrating usability and agile practices etc.) for mobile medical device software. This framework will then be introduced into the software development lifecycle within BlueBridge Technologies. In addition this research will focus on the development and validation of a mobile medical application storage and transmission security framework for ensuring that effective confidentially, integrity and availability processes in line with the FDA Cybersecurity Guidance documentation. This framework will be introduced into a new software application development lifecycle that will assist BlueBridge Technologies products to comply with the latest medical device cybersecurity regulations. The research on mobile medical software safety processes (including usability and agile practice integration) and storage and transmission cybersecurity processes will then be integrated into a single framework. The efficiency and performance of the integrated framework will then be improved through trialling and tailoring within BlueBridge Technologies.

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The main goal is to develop a fully validated best practice mobile medical software and mobile medical cybersecurity storage and retrieval framework for the development of mobile medical applications.  The RSRC will work closely with the Portable Medical Technology team to investigate the specific challenges posed by their existing mobile software development environment in relation to the development of software applications that are now subject to regulation within the medical device domain. This will form the basis of the development and validation of a best practice framework (including integrating usability and agile practices etc.) for mobile medical device software. This framework will then be introduced into the software development lifecycle within Portable Medical Technology. In addition this research will also focus on the development and validation of a mobile medical application storage and transmission security framework for ensuring that effective confidentially, integrity and availability processes in line with the FDA Cybersecurity Guidance documentation. This framework will be introduced into a new software application development lifecycle that will assist Portable Medical Technology products to comply with the latest medical device cybersecurity regulations. The research on mobile medical software safety processes (including usability and agile practice integration) and storage and transmission cybersecurity processes will then be integrated into a single integrated framework. The efficiency and performance of the integrated framework will then be improved through trialling and tailoring within Portable Medical Technology.

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The RSRC is collaborating with S3 Group on a Lero Project focused on the development of a Medical Device Software Framework. The main goal of this research is to develop a fully validated best practice medical device software and cybersecurity testing framework for the development of medical device products. The RSRC will Work closely with the S3 Group team to investigate the specific challenges posed by their existing software development environment in relation to the development of products containing evolving technology and software that are now subject to regulation within the medical device domain. This will form the basis for the development and validation of a best practice Framework (including integrating usability and agile practices etc.) for medical device software processes. This framework will then be introduced into the medical device software development lifecycle within S3 Group. In addition, this research will focus on the development and validation of a medical device security feature testing framework for ensuring that effective security testing processes are conducted in line with the FDA Cybersecurity Guidance documentation. This framework will be introduced into a new product lifecycle within S3 Group and will assist their products to comply with the latest medical device cybersecurity regulation. Following these implementations within S3 Group,  the research on medical device software processes and cybersecurity processes will be integrated into a single framework. The efficiency and performance of the integrated framework will be improved through trialling and tailoring within S3 Group.

For further information on S3 Group, please click on the link below:

http://www.s3group.com/connected-health/

The main focus of this research is the development of a testing framework for medical device software development. Verification and Validation are critical to the development of regulatory compliant medical device software. The RSRC will work closely with SQS to investigate the testing demands from the challenges posed by evolving technology and regulation within the medical device domain. This will form the basis for the development and validation of a testing framework for the medical device industry based upon integrating medical device specific verification and validation practices into the established testing framework that SQS currently implements in multiple domains. The framework will provide coverage of the complete software development lifecycle. The efficiency and performance of the medical software development testing framework will be improved through trialling and tailoring the model within SQS. This will be followed by the industrial roll-out of the end-to-end Medical Device software testing framework. Aligned to this research, the RSRC will collaborate with the Association for the Advancement of Medical Instrumentation (AAMI) on the development of a Medical Device Software Defect Taxonomy.

For further information on SQS, please click on the link below:

http://www.sqs.com/

The main aim is to develop a fully validated best practice mobile app development framework for Sports Analytics applications. The framework will also address the security of player data during transmission and storage. In addition, the usability aspect of displaying varying data across multiple devices will be addressed in the framework. The RSRC will work closely with the STATSports TechnologiesInternational team to investigate the specific challenges posed by their existing mobile software development environment in relation to the development, testing and usability of mobile Sports Analytics software applications. This will form the basis of the development and validation of a best practice Framework (including integrating usability, agile software development practices, best practice testing strategies, integrating with different types of customer applications, and player data security practices) for mobile Sports Analytics software. This framework will then be introduced into the software development lifecycle within STATSports Technologies International. . In addition this research will focus on the development and validation of a mobile application storage and transmission security framework for ensuring that effective confidentially, integrity and availability processes for player data. This framework will be introduced into a new mobile Sports Analytics software application development lifecycle that will assist their products to comply with the latest requirements in terms of the storage and transmission of player data. The research on mobile Sports Analytics software processes (including usability aspects for display of varying data across multiple devices) and player data storage and transmission processes will then be integrated into a single framework. . The efficiency and performance of the integrated framework will then be improved through trialling and tailoring within STATSports Technologies International using different customers.

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The main aim is to develop a fully validated best practice mobile medical software and mobile medical cybersecurity storage and retrieval framework for the development of medical mobile applications.  The RSRC will work closely with the Salaso Health Solutionsteam to investigate the specific challenges posed by their existing software development environment in relation to the development of software applications that are now subject to regulation within the medical device domain. This will form the basis of the development and validation of a best practice framework (including integrating usability and agile practices etc.) for mobile medical device software. The framework will then be introduced into the software development lifecycle within Salaso Health Solutions.  In addition this research will focus on the development and validation of a mobile medical application storage and transmission security framework for ensuring that effective confidentially, integrity and availability processes in line with the FDA Cybersecurity Guidance documentation. This framework will be introduced into a new software application development lifecycle that will assist Salaso Health Solutions products to comply with the latest medical device cybersecurity regulations. This research on mobile medical software safety processes (including usability and agile practice integration) and storage and transmission cybersecurity processes will then be integrated into a single integrated framework. The efficiency and performance of the integrated framework will then be improved through trialling and tailoring within Salaso Health Solutions.

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The main focus of this research is the development of a medical device software development environment to assist an organisation to efficiently develop regulatory compliant medical device software. Previously, this required adherence to medical device safety related standards however, now it is also important to also provide coverage of medical device security based standards. In relation to this project we intend to develop a framework that will incorporate processes to fulfil the medical device usability and safety requirements. This solution will be developed and validated using input from dabl Ltd. and other companies within this project in relation to the background and expectations for different types of companies. The RSRC will work with the dabl Ltd. team to investigate the specific challenges posed by their existing software development environment in relation to the development of products containing evolving technology and software that are now subject to regulation within the medical device domain. This will form the basis for the development and validation of a best practice Framework (including integrating usability and agile practices etc.) for medical device software processes and introducing this into the medical device software development lifecycle within dabl. The efficiency and performance of the integrated framework will be improved through trialling and tailoring within dabl.

For further information on dabl, please click on the link below:

http://www.dabl.ie/