MedTech Compliance
A Unified Framework
for MedTech
We integrate Quality Assurance, Regulatory Affairs, and Information Security into a single, efficient management system for medical device companies globally.
We integrate Quality Assurance, Regulatory Affairs, and Information Security into a single, efficient management system for medical device companies globally.
Pelican Tech is a division of Pelican-Tech, focusing exclusively on the medical device sector. Our mission is to empower innovation while ensuring compliance with the strictest global regulatory standards.
We bring decades of cumulative experience in guiding companies, from startups to established manufacturers, delivering actionable strategies that enable a faster, safer market entry.
Comprehensive solutions tailored for the MedTech lifecycle.
Design and implementation of ISO 13485 and FDA QMSR-compliant QMS. We prepare you for audits, manage CAPA processes, and support DHF generation.
Learn MoreEnd-to-end support for global regulatory pathways, including CE Marking (MDR/IVDR), FDA (510k, De Novo, PMA), APAC, LATAM, and Israel.
Learn MoreISO 27001 and ISO 27799 implementation tailored for MedTech. We integrate ISMS with your QMS, perform security audits, and incident response planning.
Learn MoreGDPR, HIPAA, and CCPA implementation to protect sensitive patient data (PHI). Policy design, DPIA, and breach response readiness.
Learn MoreAligning processes between quality, risk management, and information security creates seamless interaction and prevents redundancy.
A unified system simplifies compliance management and reduces operational overhead significantly.
We ensure long-term success through ongoing audits, continual improvement, and periodic training.