Medical & Devices
Clobrix provides specialized software solutions for medical device manufacturers, helping them manage product development, regulatory compliance, quality management, and post-market surveillance in one of the most regulated industries in the world.
Regulatory Compliance (FDA/CE)
Quality Management System (QMS)
Clinical Trial Management
Post-Market Surveillance
Medical device companies face intense regulatory scrutiny and quality requirements. Our software solutions help you manage the complete product lifecycle — from R&D and design control through manufacturing, distribution, and post-market activities — while maintaining full regulatory compliance.
Our Medical & Devices Solutions
We build regulatory management systems for FDA 21 CFR Part 11, ISO 13485, CE marking, and MDR compliance — managing submissions, approvals, and regulatory documentation.
Our medical device QMS solutions manage design controls, CAPA, document control, risk management, supplier quality, and audit management for ISO 13485 certification.
We develop CTMS solutions that manage clinical study planning, site management, patient enrollment, adverse event reporting, and regulatory submissions.
Our PMS systems collect and analyze real-world device performance data, manage complaint handling, and generate vigilance reports to meet regulatory requirements.
Regulatory Compliance
92%
Quality Management
90%
Clinical Management
85%