Accelerate your path to compliance when designing and developing cutting edge medical products
Developing medical devices is the ultimate balancing act. Customer expectations and complexity are ballooning, the need to move faster than the competition is paramount, but risk, certification and compliance are critical.
Flow is structured around the main medical device compliance standards stipulated by the FDA, MDR and others:
- MDR - medical device regulation 2017.45
- ISO 13485 and ISO 14971 for quality management, process and risk management
- IEC 62304 for the software elements of medical device development
- CFR Title 21 for meeting FDR regulations
Flow allows you to work in a structured and rigorous way as you manage risk, decompose down requirements and plan out verification activities.
Thomas Andrieu, Senior V&V Engineer @ Universal Hydrogen
"Flow is a game changer for us. With its simplified and easy to use interface, we can now quickly embark much more users than with traditional requirements management tools and this is key to have a "single source of trust" and avoiding disseminated and obsolete information."
"The platform allows us to efficiently manage all the requirements which are driving a complex, innovative and multi-level product like ours, it is the perfect tool when looking for agility and flexibility but while also focusing on structure and rigor."
"In my opinion, Flow is leading the new generation of system engineering tools, focused on user experience, performance and essential functionalities. Furthermore, the Flow team is regularly deploying new features based on users feedback and supports us very efficiently during the deployment of the solution to our company."
Agile Engineering: Implementing Fast, Iterative Design Process in Aerospace
A webinar with COO of Hermeus, VP of Engineering at ABL, and VP of Software Engineering at Planet. Practical advice on how to iterate faster in complex engineering projects. The webinar covers a range of topics from culture and leadership to systems mindedness and proven ways teams can increase their cycle speed.
Fast-moving team working in medical are adopting Flow
Agile requirements platform for iterative teams
Flow is the agile requirements management solution that’s lightweight enough to speed up your workflows, and rigorous enough to never worry about compliance and traceability again.
Catch design misses now and not 90 days from now. Flow helps prevent costly mistakes and get your products to market faster.
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Providing new-age engineering companies with a requirements tool that is built specifically for their needs and allows them to focus on engineering ground breaking products.