Quality System

This statement describes how Clinoble Innovations Private Limited approaches quality in its software products and its regulatory and evidence services. It is a statement of working practice, published in the interest of transparency for clients and partners.

Standards we build to

Clinoble works to the standards that govern medical-device evidence: ISO 13485 principles for design and document control, EU MDR 2017/745 and MEDDEV 2.7/1 Rev 4 for clinical evaluation, IVDR Annex XIII for in-vitro diagnostic performance evaluation, and PRISMA 2020 and GRADE for evidence synthesis. Our products are engineered so that the 510(k), De Novo and CE-MDR pathways remain open as each programme matures — architecture, traceability and evidence generation are designed around those requirements from the first commit. Certification and marking status for each programme is confirmed in writing at the point of engagement.

How we work on evidence services

• Clinical evaluation for devices under the MDR is authored against MEDDEV 2.7/1 Rev 4 and current MDCG guidance, including MDCG 2020-5 for equivalence and MDCG 2020-13 for the assessment report template. In-vitro diagnostics are handled separately under IVDR Annex XIII performance evaluation — scientific validity, analytical performance and clinical performance — not under MEDDEV 2.7/1.
• Literature work is protocol-driven with pre-specified search strategies, reproducible search strings, PRISMA 2020 flow accounting, screening logs and appraisal tables retained for audit.
• Evidence synthesis follows PRISMA 2020; where systematic reviews are conducted, protocols are registered prospectively on PROSPERO and OSF before screening begins.
• Risk of bias is assessed with instrument-appropriate tools (Newcastle–Ottawa, JBI, RoB 2, ROBINS-I) and certainty of evidence with GRADE.
• Preclinical design work references ARRIVE 2.0 reporting standards.
• Evidence gaps are surfaced early and documented in the deliverable with a remediation route, so they are closed before submission rather than raised as a Notified Body deficiency afterwards.

How we work on software

• Version control with traceable change history for all product code.
• Model performance is reported against the evaluation dataset used, with the metric and its context stated — never as an unqualified clinical claim.
• Products presented as screening aids carry in-product statements of intended use and limitations.
• Data protection is handled per our Privacy Policy; personal and health data are not processed through the corporate website.

Document control

Deliverables are issued with version identifiers and revision history. Client project records are retained for the period agreed in the engagement contract, and inputs, searches and decisions are traceable so that a reviewer can reconstruct how a conclusion was reached.

Responsibility

Clinical and regulatory deliverables are authored and signed off by a qualified physician (MBBS, MD Community Medicine). Where a programme calls for specialist input beyond our scope, we bring in a named co-evaluator so the deliverable carries the right expertise.

Roadmap

Formal QMS certification to ISO 13485 is scheduled to follow our device programmes as they advance towards submission, with the underlying practices — design control, document control and traceability — already in place. This page is updated as each milestone is reached.

Contact

Questions about our quality practices: the contact form on clinoble.com