Compliance with IEC 62304, Title 21 CFR Part 11 (FDA), ISO 14971, IEC 60601 and more
codebeamer provides an efficient way to support and prove the use of mature medical device development processes, and to achieve compliance with standards and regulations.
Its TÜV “Trusted Tool” certification proves that codebeamer adequately supports the implementation of mature and compliant lifecycle processes in the development of healthcare products.
Software quality, safety and reliability are crucial when it comes to medical systems development. Relevant quality regulations stipulated by IEC 62304, IEC 60601, ISO 14971 and other ISO/IEC/FDA standards demand:
- complete traceability of requirements all the way through to product release
- the enforcement of mature and transparent methods and processes
- adequate testing and risk management measures
- comprehensive documentation of lifecycle processes for compliance audits.
Challenges of Compliance in Medical Device Development
Compliance with relevant medical industry standards proves the safety and reliability of healthcare technology products, and may be a prerequisite to entering the market. One of the most important standards is IEC 62304 (Medical Device Software – Life Cycle Processes) which governs and describes software engineering for medical devices.
Companies and engineers operating in the medical technology sector have to understand and adhere to several other standards. These include ISO 13485 (quality management) and ISO 14971 (risk management) on one hand, IEC 62304, ISO 60601/61010 (safety and performance) and IEC 62366 (usability engineering) on the other.
Some of these regulations are not specific to software alone. ISO 13485 (Quality Management System), for example, relates to the design and also the manufacturing of medical products in general. Additionally, the Food and Drug Administration (FDA) or European Medical Device Directive may add further requirements.
Intland’s Medical IEC 62304 & ISO 14971 Template
The sophisticated features of codebeamer enable you to ensure and conveniently report on traceability, the use of mature processes, and the management of risks throughout the development lifecycle of your medical products. Its powerful features and specific medical template allow you to manage complexity, reduce time to market, and enhance efficiency even across multiple projects.
Intland’s Medical IEC 62304 & ISO 14971 Template includes functionality to achieve compliance with IEC 62304, IEC 60601, Title 21 CFR Part 11 (FDA), ISO 14971, and lets you conduct Failure Mode and Effects Analysis (FMEA) out of the box. While it comes preconfigured, you can easily custom configure the template to suit your internal processes.
About Intland Software
Intland Software help you make your software better, faster and higher quality with better processes and tools by helping you manage your software application lifecycle from Demand, Requirements, Development and Test to Delivery. More details…
Find out more…
For more information on how codebeamer can help manage the requirements for medical device development or to request Intland Software’s Medical IEC 62304 & ISO 14971 Template please complete the form below.