QARAMD Ltd
Business Coaches
QARAMD Ltd
8 Pennington Rd, Huntingdon
# QARAMD Ltd Business Description
QARAMD Ltd (trading as eQMS Innovation) is a regulatory compliance specialist based in Huntingdon that helps medical device and Software as a Medical Device (SaMD) organisations navigate complex quality management requirements. Rather than implementing entirely new enterprise systems, the company transforms existing Atlassian Jira and Confluence platforms into fully compliant electronic Quality Management Systems (eQMS).
The business serves product development teams, quality assurance departments, and regulatory affairs functions within medical device manufacturers who already use Atlassian tools for collaboration and documentation. These organisations typically struggle with the gap between their development tools and the structured, auditable processes demanded by regulators.
What sets QARAMD apart is their pragmatic approach: they configure familiar tools rather than forcing adoption of rigid, unfamiliar QMS software. This reduces implementation complexity whilst maintaining alignment with ISO 13485, ISO 14971, IEC 62304, and FDA 21 CFR Part 820 standards. Their solution delivers end-to-end traceability between requirements, risks, verification activities, and documentation—critical for regulatory submissions and audits.
The company provides system configuration, quality documentation structure setup, traceability architecture, and team onboarding. By working within the Atlassian ecosystem, they enable regulated teams to maintain productivity whilst achieving and demonstrating regulatory compliance.
QARAMD Ltd (trading as eQMS Innovation) is a regulatory compliance specialist based in Huntingdon that helps medical device and Software as a Medical Device (SaMD) organisations navigate complex quality management requirements. Rather than implementing entirely new enterprise systems, the company transforms existing Atlassian Jira and Confluence platforms into fully compliant electronic Quality Management Systems (eQMS).
The business serves product development teams, quality assurance departments, and regulatory affairs functions within medical device manufacturers who already use Atlassian tools for collaboration and documentation. These organisations typically struggle with the gap between their development tools and the structured, auditable processes demanded by regulators.
What sets QARAMD apart is their pragmatic approach: they configure familiar tools rather than forcing adoption of rigid, unfamiliar QMS software. This reduces implementation complexity whilst maintaining alignment with ISO 13485, ISO 14971, IEC 62304, and FDA 21 CFR Part 820 standards. Their solution delivers end-to-end traceability between requirements, risks, verification activities, and documentation—critical for regulatory submissions and audits.
The company provides system configuration, quality documentation structure setup, traceability architecture, and team onboarding. By working within the Atlassian ecosystem, they enable regulated teams to maintain productivity whilst achieving and demonstrating regulatory compliance.
Services offered
eQMS configuration on Jira and ConfluenceISO 13485 compliance implementationrisk management system setup (ISO 14971)design control documentationchange management workflow configurationtraceability mapping and linkingteam onboarding and trainingregulatory audit readiness preparation