Innolitics staff has 20 years of experience in providing regulatory strategy, design documentation, and submissions for Software as a Medical Device (SaMD) and Software in Medical Devices (SiMD). We can help you make the correct choices to obtain timely and cost-effective market access in the United States, EU, UK, and Canada:
Initial regulatory assessments,
Creation of intended use (which drives the regulatory pathway),
US, EU, UK, and Canadian device classification and regulatory pathway,
Authoring and submitting the regulatory submission,
Lead interaction with governmental agencies during submission review,
Guidance related to creation of required Quality Management System (QMS),
Post-market regulatory assistance (e.g., assessment and documentation of product changes).