Our Services
Whether you’re a large corporation with products on the market or an early-stage startup with no clearances or formal processes, SaMD Compliance can help you reach your goals.
Premarket Submissions
Our expert team collaborates with you to create a customized regulatory strategy, design and execute clinical evaluations, manage potential risks, incorporate your SaMD into a compliant Quality Management System, and prepare and submit all essential documentation, including 510(k) clearances, De Novo requests, and PMA applications.
Presubmission and Precollaboration with FDA, Notified Bodies or Other Regulators
Our services ensure strategic presubmission consultations and pre-collaboration with the FDA, Notified Bodies, and other relevant regulatory entities. By facilitating these early-stage discussions, we foster clarity around your product’s regulatory pathway, expediting approvals and mitigating potential roadblocks.
Quality Management Systems (EN ISO 13485)
Our comprehensive QMS services include gap analysis, customized QMS design, implementation support, and continuous improvement, all designed to streamline your development process, enhance efficiency, and keep your SaMD product compliant with evolving industry standards and best practices.
CE Marking
CE Marking is a critical step for market access in the European Economic Area. We provide comprehensive guidance through the complex process of conformity assessment, ensuring your SaMD complies with the essential requirements outlined in the EU’s Medical Device Regulation (MDR). Our services streamline your path to CE marking for faster market entry.
Health Canada Approval
Meeting Health Canada’s regulatory requirements is crucial for market entry. We offer comprehensive support towards securing the necessary Medical Device License (MDL), leveraging our extensive knowledge of the Canadian regulatory landscape. Our expertise can help you quickly navigate the approval process so your SaMD product can contribute significantly to the Canadian healthcare sector.
Automated Testing and Documentation
Turbocharge your Verification and Validation documentation process with our Azure integration. Combining the flexibility and features of Azure DevOps with automated testing, document generation, and a single environment for cross-traceable risks, requirements, and tests, our platform is a scalable solution for compliance at high speed.
MDSAP Compliance
Our MDSAP services provide extensive guidance and support to ensure your SaMD product meets the stringent requirements of this international audit program. With profound insight into the intricacies of MDSAP and its alignment with various regulatory jurisdictions, we facilitate your path to MDSAP compliance, enabling broader market access while maintaining a high standard of product quality and safety.
Audit Preparedness
Face audits with confidence. Our services cover internal audits, audit readiness reviews, documentation support, personalized coaching, on-site audit support, and post-audit support to resolve any nonconformities. Harnessing our deep understanding of SaMD-specific regulations and standards, we fortify your compliance posture to ensure audit resilience and long-term success.
Ready to get started?
Let us help bring your SaMD product to market!
