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Medical Devices: Accelerate your path to compliance by meeting certification standards.
Rigour and compliance whilst maintaining speed.
Stay Aligned with Standards and Regulations & Move at Speed
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:
- 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.
Powering the Pioneers of the Next Frontier
Modern engineering teams are moving to Flow
Supercharge development with Flow's next-generation requirements platform
Flow is the requirements management solution you've been waiting for. Lightweight enough to speed up your workflows, and rigorous enough to never worry about compliance and traceability again.
Don't wait to discover today's mistakes 90 days from now, add Flow now to prevent costly mistakes and accelerate your development.
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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.