The Catalyst to Your Innovation
At Calytra, we empower early-stage medical device innovators to navigate complex regulatory landscapes and drive transformative progress.
Schedule a ConsultationCalytra is a specialized consultancy dedicated to transforming groundbreaking ideas into market-ready medical devices. Our team of experts combines strategic insight with regulatory expertise to guide you from pre-IDE planning through post-IDE execution.
With a passion for innovation and a commitment to excellence, we work closely with our clients to ensure every project not only meets but exceeds industry standards.
Expert guidance on navigating FDA regulations, pre-IDE planning, and IDE submissions.
From concept to prototype, we refine your design to meet the highest standards of safety and efficacy.
We craft tailored DV strategies that integrate sterilization, packaging, and shelf-life testing—ensuring your device meets standards and is market-ready.
Strategic planning and support for clinical trials, ensuring robust data and compliance.
ISO 14971, ISO 13485, ISO 10993, ISO 11607, ISO 11135, IEC 60601, 21 CFR 820, SOR/98-282
Tailored solutions to decrease time to market, ensure shelf-life and microbial barrier, while maintaining easy paths to validation.
Medtech executive with 10+ approved IDEs, multiple global regulatory approvals, and more than a decade driving innovation in complex regulatory landscapes. Former VP at an ISO 13485–certified MN Cup winner. Previously managed $80M/year in tech dev at a Fortune 100.
Veterinary public health expert with a track record of supporting preclinical strategy, regulatory compliance, and global study design at a Fortune 100. DACVPM-certified with a dual DVM/MPH background and expertise in GLP, AALAC, and IACUC frameworks.
Stay ahead with the latest trends, regulatory updates, and breakthrough innovations in the medical device industry. Our insights help you make informed decisions at every stage.
Ready to transform your medical device innovation journey? Reach out to us today.