Device/IVD Regulatory Affairs & Regulatory Technology

“We cover a full spectrum of innovative and complex integrated device technologies, including combination products, medical devices, IVDs/CDx, and digital health technologies.”

“RIMS end-to-end implementation (assessment, configuration, migration, change management, training, implementation, and maintenance)”

“DCN Dx provides regulatory strategy and submission support for diagnostic devices throughout the product lifecycle.”

“Drawing on deep experience with FDA, EU MDR/IVDR, Health Canada, and other global pathways, we help clients choose the right approach for their device and business model —…”

“Rook specializes in Quality and Regulatory strategies for early-stage medical device clientele, providing expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance…”

“In the United States, Veristat supports MD and IVD manufacturers in obtaining FDA clearance or approval.”

“Simplify complex regulatory journeys backed by our seasoned experts, including former FDA and Notified Body reviewers. We embed strategy early to streamline submissions, reduce…”

“Castor supports registry, survey, and chart review PMCF designs with structured data exports and full audit trails.”

“Pre-submission Support (510k, PMA, IDE, De Novo) If requested, protocol development is available as a standalone service to aid in the pre-submittal process.”

“…Medical Devices Device registration across all risk classes, including Class I, II, and III, aligned with COFEPRIS device regulations.”

“…Clinical evaluation reports”

“510(k) Application: Guiding you through the 510(k) application process for medical devices, ensuring market access while meeting regulatory standards”