A Unified Framework for MedTech Compliance

We integrate Quality Assurance, Regulatory Affairs, and Information Security into a single, efficient management system for medical device companies in Israel, Europe, the US, and other key global markets.

Who We Are

Pelican MedTech 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.

Our Integrated Approach

The Unified Management System

At Pelican MedTech, we don’t just offer services; we build integrated frameworks.

Our unique approach combines Quality Assurance (QA), Regulatory Affairs (RA), and Information Security (ISMS) into a single, cohesive management system.

This streamlined methodology enhances compliance, improves efficiency, and reduces operational costs for your medical device.

Our Services

Quality Assurance (QMS)

Design and implementation of ISO 13485 and FDA QMSR-compliant QMS. We prepare you for audits, manage CAPA processes, conduct risk management, and support DHF generation for hardware and software.

Regulatory Affairs (RA)

End-to-end support for global regulatory pathways, including CE Marking (MDR/IVDR), FDA (510k, De Novo, PMA), APAC, LATAM, Russia and CIS (Commonwealth of Independent States) and Israel.

Information Security (ISMS)

ISO 27001 and ISO 27799 implementation tailored for MedTech. We integrate the ISMS with your QMS, perform security audits, and provide incident response planning.

Privacy & Compliance

GDPR, HIPAA, and CCPA implementation to protect sensitive patient data (PHI). We handle policy design, Data Protection Impact Assessments (DPIA), and breach response readiness.

Why Our Integrated Approach Works

Enhanced Efficiency

Aligning processes between quality, risk management, and information security creates seamless interaction and prevents redundancy.

Reduced Costs

A unified system simplifies compliance management and reduces operational overhead.

Sustained Compliance

We ensure long-term success through ongoing audits, continual improvement, and periodic training.