Leveraging Traceability In Medical Device Development
Innovation in the Medical Device Development industry is hampered by complex standards and regulations and once the medical device prototype is developed and tested, it then faces a long approval process. Traceability is essential for ensuring compliance with medical device standards and regulations but this often overshadows its most important function as an enabler for collaboration on development, – greatly improving development decision-making (and increasing the speed of decision making). The benefits of traceability can be leveraged in other ways too, for example, for risk management and change management. Complete traceability from project start to finish, once experienced cannot be done without, such are the benefits gained in terms of simplifying compliance, shortening the development lifecycle and cutting costs of development.
codeBeamer ALM provides complete traceability on Medical Device Development projects via our tailored Medical Template. This template is designed specifically for Medical Device software development, leveraging the advanced capabilities of codeBeamer ALM to address the special needs of medical device developers seeking compliance with relevant standards such as IEC 62304, FDA Title 21 CFR Part 11, IEC 60601, and ISO 14971.
With clients like Medtronic, the world’s largest standalone medical technology development company you can be rest assured that this is the best solution for developing software for embedded devices such as medical devices. Do not just take our word for it. Ovum has labelled Intland Software’s codeBeamer ALM a Leading ALM solution in Ovum’s 2016 -17 Decision Matrix.
Many other ALM solutions rely on many plugins to even come close to what codeBeamer provides natively and all from a single repository (data store). It even includes advanced digital documents management, recording all changes to medical documentation and product requirements (via web interface or via Word and Excel roundtrip). codeBeamer ALM can be easily integrated with any PLM system (and any other ERP software) thanks to its innovative Business Process Management (BPM) module.
Do you have a range of medical device products with many similarities?
codeBeamer ALM features include advanced requirements management and requirements reuse, simply duplicate and rename the requirements and its ready to go for another product. The management of development of several product types in a product line can be a challenge which is why codeBeamer built in Variants Management a feature that prevents redundant rework, all variations are strictly defined, and shared features can be reused in different product variants. codeBeamer helps you to keep track of multiple medical device variants, enabling efficiency in medical device development.
Learn more about codeBeamer ALM and why Ovum branded us a market leader.