BioT and Orcanos Announce Strategic Partnership to Connect Medical Device Cloud with eQMS and ALM

Tel Aviv, December 21, 2025. BioT, the regulated cloud platform for connected medical devices, and Orcanos, a provider of eQMS and ALM software for medical device companies, have announced a strategic partnership to integrate regulated cloud operations with design control and quality management.

The integration links BioT’s medical device cloud platform with Orcanos’ combined ALM and eQMS suite. The goal is to achieve faster submissions, tighter traceability, and a lower operational burden for quality and R&D teams.

The Problem: A Broken Feedback Loop

Medical device companies use separate systems for quality management and device cloud operations. Design control sits in QMS. Device deployment, patient data collection, and remote updates run in the cloud. Post-market surveillance data rarely flows back automatically into CAPA and complaint management.

As regulatory requirements for continuous post-market surveillance and cybersecurity incident management grow under the FDA and MDR, this fragmented approach introduces compliance risks and increases manual work.

What Joint Customers Get

• Single system of record from cloud to quality. Device data, configurations, logs, and analytics in BioT map to Orcanos design control, document control, and records for DHF, DMR, and audits.
• Closed-loop quality. CAPA, complaints, and training in Orcanos are linked to real device evidence from BioT, enabling faster root cause analysis and verified closure.
• State-of-the-art Real-world evidence. BioT collects structured device telemetry and usage data from the field with consent and controls. Orcanos links this evidence to risk files, CAPA, and design history. Teams support PMCF, PMS, PSUR, and clinical evaluation with traceable data, reducing manual effort and gaps.
• Risk management that reflects the real world. BioT events and post-market insights enrich Orcanos FMEA and hazard files with live context.
• Submission speed. BioT’s complete Design History File (DHF) and validation evidence package becomes part of the Orcanos offering. Device manufacturers get pre-validated cloud documentation, eSTAR attachments, and traceability matrices ready for FDA and notified body review.

Executive Perspectives

“Every connected device company we talk to faces the same challenge. They finish design control in their QMS, launch the device, then scramble to figure out how to collect post-market data and feed it back into their quality system,” said Daniel Adler, CEO of BioT. “This partnership removes those handoffs. Quality and engineering move as one team, from design through post-market.”

“Medical device companies should focus on building great devices, not integrating disconnected software systems,” said Rami Azulay, CEO of Orcanos. “By embedding BioT’s cloud infrastructure and compliance package directly into our platform, we give customers a complete quality and operations backbone. One vendor relationship. One integrated DHF. Faster time to market.”

About BioT

BioT provides secure, regulated cloud infrastructure for connected medical devices. The platform serves MedTech companies across all verticals and intended uses, supporting devices deployed in hospitals, clinics, and at home. BioT is FDA-ready, HIPAA compliant, SOC 2 Type II certified, HITRUST r2 certified, ISO 27001 certified, and ISO 13485 certified. Learn more at biot-med.com.

About Orcanos

Orcanos delivers integrated eQMS and Design Control (ALM) software purpose-built for medical device companies. The platform unifies design control, risk management, document control, and post-market quality processes in a single cloud system. Orcanos serves customers including GE Healthcare, Medtronic, and leading MedTech innovators. Learn more at orcanos.com.