The promise of SaMD

Software as a Medical Device (SaMD) is poised to change how patients and health care providers interact, and it’s streamlining the way data is shared, tracked and analyzed. This has huge implications for biopharma and medtech companies, whose success depends on matching the right patients with the right diagnostics and treatments—and making a compelling case for reimbursement with payers.

BrightInsight is the industry leader in bringing regulated SaMD solutions to market. Learn more about how BrightInsight’s compliant platform accelerates time to market for leading biopharma and medtech companies’ SaMD solutions.

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Expectation vs. Reality: Cost and Time to Bring SaMD to Market

Insights from top digital health executives on how to speed time to market and lower costs for SaMD solutions.

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Everything You Need to Know About Software as a Medical Device (SaMD)

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Roche: How BrightInsight Accelerated Time to Market for a Software as a Medical Device (SaMD) Solution

Roche developed a digital dosage calculator to aid prescribing physicians and maximize Hemlibra’s therapeutic benefits for patients with Hemophilia A. Rather than engineer their own infrastructure, applications and data stores, Roche partnered with BrightInsight and significantly accelerated time to market.

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Data Snapshot:
Promising SaMD Use Cases

While the potential applications for SaMD are myriad, a recent survey found that disease management was the most promising use case.

3 Things You Need to Know About the FDA's New Software as a Medical Device (SaMD) Guidance

This new guidance from the FDA has important information for anyone operating in the digital health space.

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3 things you need to know


SaMD Compliance: How the US and EU Approach Regulations

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How to Launch Regulated Software as a Medical Device in 6 Months’ Time

Learn more about how Roche launched a CE-marked dosing calculator to treat Hemophilia A in just 6 months in this conversation with Paul Upham, Head of Smart Devices at Roche/Genentech.

Webinar how to launch regulated software as a medical device in 6 months time

SaMD Resources