You're under increasing pressure to comply with regulations (FDA, ISO, SOC 2, HIPAA), and you're not sure where to turn.
You're juggling multiple siloed tools - QMS, risk register, training, GRC, audits - and it's costing you time and money.
Fragmented tools are causing duplicate work, audit risk, and consulting costs - and it's dragging on your time-to-market.
The Marriage of QMS + GRC
No other platform combines the power of QMS and GRC like this
All-in-One Compliance
Why invest in disjointed QMS and GRC tools? Control map across FDA, ISO, SOC 2, HIPAA (and more!) on single compliance platform.
Faster Time-to-Market
Accelerate document control, CAPA, training, and audit prep to propel your SaMD products to market sooner.
Out-of-this-World Pricing
Replace the costs + headaches of multi-tool management with integrated reporting to simplify compliance and reduce licensing costs.
Welldoc Achieves Zero Findings in MDSAP Audit with Ostendio
Welldoc achieved a rare zero-finding result in their MDSAP re-certification audit, a testament to their robust compliance processes.
Powerful Features for SaMD Compliance
Document Control
Audit Management
CAPA Workflows
Risk
Management
Training Management
Cybersecurity Compliance
What You Can Expect
- Cut compliance tools and consulting costs by 50% or more
- Align product, quality, and security teams on a single platform
- Speed time-to-market by demonstrating trust to buyers + regulators
- Pass SOC 2, HITRUST or HIPAA audits with up to 80% time savings
Accelerate FDA and ISO 13485 readiness
A QMS Shouldn't Stop at Documentation...
For FDA-regulated SaMD companies, audit readiness is table stakes. A dynamic QMS keeps your team aligned, prepared, and a step ahead of regulatory shifts.
Sound Too Good To Be True?
Check out the solutions to these common concerns.
Or better yet, schedule a demo and put us to the test!
Can one platform really serve both QMS and GRC needs?
Yes! Ostendio blends the best of GRC + QMS functionality and is backed by experience serving SaMD and medical device clients.
Our unified platform ensures that both quality and IT teams have access to tailored tools within a single interface, reducing duplication and enhancing collaboration.
How do we manage different departments using the same platform?
We understand that QMS is typically managed by quality teams, while GRC is handled by IT or security teams.
Ostendio offers role-based access and customizable dashboards, allowing each department to focus on their specific workflows while sharing critical data seamlessly.
Our onboarding team provides training to align both teams on shared goals.
Will integrating QMS and GRC overwhelm our team?
Not at all. Ostendio’s design and dedicated support simplify adoption.
We provide step-by-step onboarding, tailored training, and ongoing assistance to ensure both quality and security teams can leverage the platform without added complexity.
Exclusive Pilot Program
Ready to Transform Your SaMD Compliance?
Join us to validate and refine a solution built for your industry’s future.
- Access full QMS and GRC features at a fraction of the cost.
- Join our advisory board to shape SaMD-specific features.
- Receive dedicated onboarding and support.
