For developers of digital health tech products, ensuring compliance is a crucial concern – and a resource-intensive process. Stringent FDA regulations require MedTech innovators to implement mature development processes, gapless traceability, and documented transparency along the product delivery lifecycle.
codebeamer X is an easy-to-use and effective Agile Requirements, Risk, and Test Management platform for developers of medical technology.
Leading global digital healthcare innovators are using our ultralight, intuitive, and mobile-ready solution to comply with MedTech regulations including FDA’s Title 21 CFR Parts 11 and 820.