Reliza and MedWare Cyber Announce Strategic Partnership to Streamline Medical Device Compliance
2026-08-24
Ottawa, ON, August 24, 2026 — Reliza Incorporated, the company behind ReARM, an open-core release governance and SBOM/xBOM lifecycle management platform, today announced a strategic partnership with MedWare Cyber, a leading provider of end-to-end cybersecurity and regulatory consulting for medical devices under FDA and EU MDR frameworks.
The partnership combines MedWare Cyber's deep expertise in premarket submissions — including 510(k), De Novo, PMA, and EU MDR technical documentation — and in related standards such as ISO 13485, IEC 62304, and IEC 81001-5-1 with ReARM's automated software and hardware supply chain transparency capabilities. Together, the two companies will help medical device manufacturers meet the cybersecurity requirements of Section 524B of the FD&C Act, including SBOM generation and maintenance, vulnerability monitoring, and secure product development framework evidence, as well as corresponding expectations under EU MDR and the Cyber Resilience Act.
"Medical device manufacturers are now expected to demonstrate continuous software transparency — not just at submission time, but across the entire product lifecycle," said Pavel Shukhman, CEO of Reliza. "Partnering with MedWare Cyber lets us pair that technical foundation with the regulatory strategy manufacturers need to actually get through premarket review."
"Cybersecurity documentation has become a frequent source of deficiency letters we see in premarket submissions. Manufacturers often treat the SBOM as a one-time deliverable, when FDA expects it to be a living artifact maintained across the product lifecycle. Partnering with Reliza means our clients can generate and maintain their SBOMs automatically, so we can focus on secure development processes and standards alignment rather than manually assembling component inventories," said Joseph Silvia, CEO of MedWare Cyber.
Under the partnership, MedWare Cyber clients will gain access to ReARM for SBOM, HBOM, and broader xBOM lifecycle management, release governance, and vulnerability disclosure workflows, including ReARM's distribution module, which tracks device instances deployed at specific fielded sites, such as individual hospitals. Reliza customers, in turn, will be able to engage MedWare Cyber for premarket cybersecurity strategy, standards alignment, submission preparation, and post-market compliance support.
About Reliza
Reliza Incorporated is a Canadian company building ReARM, an open-core platform for release governance and SBOM/xBOM lifecycle management, serving regulated industries. Learn more at rearmhq.com.
About MedWare Cyber
MedWare Cyber is a cybersecurity firm operating at the intersection of patient safety and cybersecurity, dedicated to protecting medical devices and healthcare technology from evolving cyber threats. The company partners with medical device manufacturers and health delivery organizations (HDOs) to deliver vulnerability assessments, penetration testing, incident response, compliance consulting, security risk assessments, audits, and cybersecurity training. MedWare Cyber's team works within established global regulatory and industry frameworks, including FDA premarket and post-market cybersecurity guidance, ISO 13485, ISO 14971, IEC 62304, IEC 81001-5-1, the HIPAA Security Rule, GDPR, EU-MDR, MDCG, and NIST cybersecurity standards to help healthcare organizations safeguard patient data, ensure the integrity of connected medical devices, and maintain regulatory compliance. Headquartered with offices in Boston, Massachusetts; Long Beach, California; and Huntsville, Alabama, MedWare Cyber serves clients ranging from small businesses to Fortune 500 companies. Learn more at www.medwarecyber.com.
Media contact: media@reliza.io