Whether you specialize in AI or traditional software, we are your experts in SaMD compliance and international market access.
With a century of collective expertise in navigating regulatory requirements and quality standards, our team guides your SaMD product through the intricacies of compliance. From premarket submissions to quality management systems and audit preparedness, we deliver market access at minimal cost.
Regulatory compliance is complex. It doesn’t have to be complicated.
The global regulatory environment can be daunting without guidance and support.
We simplify the SaMD compliance journey so you can focus on what you do best—creating life-changing solutions for health care.
21 CFR Part 820
From start to finish, we can design and help you implement your Quality Management System.
21 CFR Part 11
We specialize in scalable compliance for electronic records controls.
ISO 13485 and 14971
Have the confidence of knowing you’re audit-ready for quality management and risk management certification.
EU MDR
Don’t let the new MDR’s higher standards keep your product out of the EU. Our experts can make compliance easy.
Canada MDR
We have decades of experience helping companies comply with Health Canada’s requirements.
MDSAP
Take advantage of a single audit for QMS compliance in Australia, Brazil, Canada, Japan, and the US.
A record of success that you can trust.
Our team has a long track record of successfully designing and implementing internationally compliant Quality Management Systems, submitting successful 510(k) and De Novo applications, and interfacing with Notified Bodies on high-stakes certification audits.
Ready to get started?
Let us help bring your SaMD product to market!
