Development of the Medi SPICE PRM (original) (raw)
Related papers
Development of a Process Assessment Model for Medical Device Software Development
Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions (principally the EU and the US). In order to satisfy jurisdictional regulations, developers of medical device software generally implement standards and guidance provided by international standards bodies and national administrative departments. However, the various standards and guidance documents are not developed as a single cohesive set but often as separate resources addressing distinct areas of concern. The result for medical device software developers is that integration of these various sources represents a challenging undertaking. The aim of this paper is to describe the integration of the several process models and regulatory standards, first, into a process reference model and then into a process assessment model for medical device software development. The focus is on the integration of regulatory standards from the medical device domain with generic software development process models, resulting in a unified best practice framework for medical device software development. The process reference model for medical device software development is going to be published this year as IEC TR 80002-3, and the process assessment model for medical device software development is currently being validated through pilot studies in medical device industry. This best practice framework will help small software developers in their adoption of regulations-compliant best practices while reducing the overhead associated with understanding the long list of regulations and standards they need to adhere to when developing software for medical devices. This framework will also help the manufacturers in selecting their software suppliers assuring that the suppliers have adopted the best practices and are compliant with the medical device standards and regulations.
Development of MDevSPICE® - the medical device software process assessment framework
Journal of Software: Evolution and Process, 2015
Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions. In order to satisfy jurisdictional regulations, developers of medical device software adopt standards and guidance provided by international standards bodies and regulators. However, the various standards and guidance documents are often not developed as a single cohesive set resulting in a complex and costly challenge for medical device software developers when complying with regulation. The aim of this paper is to describe the integration of medical device guidance documents and software engineering standards into a unified framework for medical device software process assessment called MDevSPICE®. The paper illustrates the development of both the process reference model and the process assessment model (PAM) of MDevSPICE®. The MDevSPICE® PAM can help software developers to prepare for the regulatory audits, which they must satisfy as a prerequisite to placing their products on the market. The MDevSPICE® PAM can also assist medical device manufacturers to select competent software suppliers.
A recent revision to the European Medical Device Directive (MDD) 2007/47/EC made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the de-velopment of software for use in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device and should be developed following state of the art medical device software development processes. State of the art medical device software processes is understood within the industry as developing software in accordance with IEC 62304 and standards that are aligned with it. This paper identifies how changes to the MDD affect medical device software development companies and recommen-dations are made as to how medical device software development companies can conform to the latest regulatory requirements. Additionally, the paper provides an overview of how Medi SPICE is currently being developed to provide organisations with a single point of reference for the practices that should be implemented in order to produce regulatory compliant medical device software.
The Need for a Software Process Improvement Model for the Medical Device Industry
2007
Software is becoming an increasingly important aspect of medical devices and medical device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well documented processes is important within the domain of medical device software. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies (e.g. the Food and Drug Administration (FDA)) is achieved. This paper outlines the development of a software process improvement (SPI) model specifically for the medical device industry. The paper details how medical device regulations may be satisfied by adopting relevant practices from the Capability Maturity Model Integration ( CMMI®). Copyright © 2006 Praise Worthy Prize - All rights reserved.
A Lightweight Assessment Method for Medical Device Software Processes
Communications in Computer and Information Science, 2014
This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the medical device industry. MDevSPICE is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed.
Implementation of a lightweight assessment method for medical device software
This paper outlines the development and implementation of Medi SPICE-Adept. Medi SPICE-Adept is a lightweight assessment method that has been designed for usage with the Medi SPICE software process assessment and improvement model which is currently being developed for the medical device industry. While the Medi SPICE model is detailed and comprehensive in its approach there is industry demand for a lightweight medical device process assessment and improvement method. To address this requirement Medi SPICE-Adept has been developed. Details on how this has taken place and the procedures for implementing a Medi SPICE-Adept assessment are presented. Information is also provided regarding how a Medi SPICE-Adept assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed
The Development and Current Status of Medi SPICE
Communications in Computer and Information Science, 2013
There is increasing demand for effective software process assessment and improvement in the medical device industry. This is due to the expanding and complex role that software now plays in the operation and functionality of medical devices. This paper outlines the development and current status of Medi SPICE a software process assessment and improvement model which is being developed to meet the specific requirements of this safety-critical domain. This includes the selection of the most appropriate software process improvement model on which to base Medi SPICE. Its initial development and restructuring to conform to ISO/IEC 15504-5:2012 and ISO/IEC 12207:2008. The structure and content of its process reference model is outlined and an industry based trial assessment of 11 of its processes discussed. Current and future work is considered including the timeframe for the release of a full version of the Medi SPICE model.
Medi SPICE and the Development of a Process Reference Model for Inclusion in IEC 62304
The demand for medical device software continues to grow and there is an associated increase in its importance and complexity. This paper discusses medical device software process assessment and improvement. It outlines Medi SPICE, a software process assessment and improvement model which is being developed to meet the specific safety critical and regulatory requirements of the medical device domain. It also details the development of a subset of the Medi SPICE process reference model for inclusion in the next release of the IEC 62304 standard: Medical device software Software Life Cycle processes. IEC 62304 is a key standard for medical device software development and is approved by many national regulatory bodies including the Food and Drug Administration in the United States and the European Union. This paper also outlines 3 lightweight software process assessment methods which have been developed in tandem with Medi SPICE. Finally the time line for the release of the full Medi SPICE model is provided.
Envisioning a Requirements Specification Template for Medical Device Software
Lecture Notes in Computer Science, 2014
In many health jurisdictions, software is considered to be medical device software (MDS), when it is used to analyze patient data in order to render a diagnosis or monitor the patient's health; when it is to be used by a patient to diagnose an ailment; or when it is used to deliver functionality for a medical device. Flaws in MDS can result in patient harm, including death. Legislators and regulatory agencies publish guidelines and regulatory standards that are aimed at ensuring the safety, security and dependability of MDS. These guidelines and standards universally agree that a complete and consistent requirement specification is vital to the success of medical device software. Moreover, we observe that regulators are shifting from being process focused to being product focused in their approval guidance. In this paper, we review challenges associated with requirements used in the development of MDS, current standards and guidelines relevant to MDS, and existing templates for requirement specifications. We then propose a set of design objectives for a 'good' MDS requirements template and propose a template structure for MDS requirement specification fulfilling all the design objectives. Our template is, by design, tailored to facilitate the gathering and documenting of high quality requirements for MDS.
How amendments to the Medical Device Directive affect the Development of Medical Device Software
A recent revision to the European Medical Device Directive (MDD 2007/47/EC) made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the de-velopment of software for use in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device. Prior to this amendment medical device software was developed in accordance with the IEC 62304 standard. However, IEC 62304 is not sufficiently comprehensive to provide guidance in the development of standalone software as an active medical device. Medi SPICE is currently being developed to fill the gaps left by IEC 62304 in developing standalone software as an active medical device and to provide medical device software developers a single point of reference for developing software for use in healthcare.