SPICE Medical Devices

Medical Devices Software Process Assessment

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CMMI and Medical Device Standards

I have published the attached white paper comparing IEC 62304 and ISO 13495 with the CMMI-DEV 1.2. The paper shows overwhelmingly that the CMMI can provide significant support for the standards AND lead to productivity and effectiveness that is not…Continue

Started by David W. Walker in News Feed Nov 10, 2010.



Medical device companies must ensure that they comply with medical device regulations and must produce a design history file detailing the software components and processes undertaken in the development of their medical devices. Due to the safety-critical nature of medical device software it is important that efficient and effective software development practices are in place within medical device companies.

To this end, the Center for Devices and Radiological Health CDRH) has published guidance papers for industry and medical device staff which include risk -based activities to be performed during software validation, pre-market submission and when using off-the-shelf software in a medical device. Although the CDRH guidance documents provide information on which software activities should be performed, including risk based activities; they do not enforce any specific method for performing these activities.

SPICE Medical Devices

SPICE Medical Devices aims to define a conformity assessment approach for the medical device industry to support first, second and/or third party medical device software process assessments which may be recognized by the regulatory bodies and pave the way for a more streamlined pathway towards compliance.

The overall approach also aims to provide an efficient and effective mechanism for assessing and improving processes for medical device software irrespective of conformity assessment and requirements for compliance.

SPICE Medical Devices will develop a Process Reference Model (PRM) and Process Assessment Model (PAM) for Medical Device Software that is conformant to the requirements of ISO/IEC 330xx family of standards and which integrates other relevant standards as determined by the stakeholders. Relevant standards may include the FDA and European Council guidelines and associated standards (e.g. FDA 21 – CFR Part 820, 93/42/EEC, ISO 14971, IEC 60601-1-4, IEC 62304, IEC 80002-1 (the replacement for TIR 32) and ISO 13485).

The overall approach will be to define the set of processes that will cover the complete medical device software development and maintenance life cycle including the eleven software development areas defined by the FDA, the European Council, and the main process groups that are defined in IEC 62304.

As safety is a primary issue for Medical Device Software, SPICE Medical Devices will provide an integrated approach to the use of the safety integrity levels and the safety life cycle from IEC 61508 (the international standard for the “functional safety” of electrical, electronic, and programmable electronic equipment) and the safety extensions that are currently defined as part of ISO/IEC 15504-10.

SPICE Medical Devices is an initiative of the SPICE User Group.




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