MDCN Studio is the platform that covers CDSCO MDR 2017, ISO 13485:2016, FDA 21 CFR Part 11, and EU MDR 2017/745 simultaneously. Here is exactly how.
Schedule 5 QMS requirements — full coverage
Key clauses Sections 4–8 — full coverage
Applicable sections — full coverage
Annex IX requirements — EUDAMED API roadmap Q3 2026
India's primary medical device regulatory framework. Schedule 5 defines the Quality Management System requirements for all licensed manufacturers. All 12 Schedule 5 requirements are covered in MDCN Studio.
| Clause | Requirement | MDCN Studio Coverage | Module |
|---|---|---|---|
| Schedule 5, Para 1 | Quality Management System — documented QMS covering all manufacturing activities | Document Control with QMS document hierarchy; SOP templates pre-configured for Schedule 5 | Documents |
| Schedule 5, Para 2 | Document control — version control, approval, distribution of quality documents | Version-controlled document lifecycle: Draft → Review → Approved → Superseded; role-based approval gates | Documents |
| Schedule 5, Para 3 | Records control — identification, storage, protection, retention, disposal | Immutable record storage with S3 Object Lock WORM; configurable retention periods; role-based access audit | Documents |
| Schedule 5, Para 4 | Management responsibility — quality policy, objectives, management review | QMS Tracker for management review agenda, minutes, action items; quality objectives tracking | QMS Tracker |
| Schedule 5, Para 5 | Resource management — human resources, training, competency records | Training module: role-based training assignment, completion tracking, competency assessments | Training |
| Schedule 5, Para 6 | Product realisation — planning, design, purchasing, production controls | DHF, Travellers, Shipments, Supplier Management with approved vendor controls | DHF · Travellers · Suppliers |
| Schedule 5, Para 7 | Purchasing controls — supplier qualification, incoming inspection | Supplier qualification workflow; approved vendor list maintenance; supplier audit scheduling | Suppliers |
| Schedule 5, Para 8 | Non-conformance control — identification, segregation, disposition | NCR module: identification, root cause, disposition, CAPA linkage | CAPA & NCR |
| Schedule 5, Para 9 | Corrective and preventive action — root cause, action plan, effectiveness verification | CAPA module: structured 8D workflow, action plan with owner/due date, effectiveness review gate | CAPA & NCR |
| Schedule 5, Para 10 | Internal audit — planned audits, findings, corrective actions | Audit Management: annual audit schedule, checklist-based findings, CAPA linkage | Audits |
| Schedule 5, Para 11 | Complaint handling and post-market vigilance | CRM module: customer complaint logging, investigation, reporting, trend analysis | CRM |
| Form 34B | Manufacturing licence inspection — document readiness for CDSCO inspector | Audit-ready dashboard: one-click document package assembly for Form 34B inspection categories | Documents · QMS Tracker |
The international standard for medical device QMS. Mandatory for CE marking and required by most export markets. MDCN Studio covers all 28 key clauses in Sections 4–8.
| Clause | Requirement | MDCN Studio Coverage | Module |
|---|---|---|---|
| §4.1 | General QMS requirements — processes, sequence, interactions | QMS process map; inter-module workflow linkages (audit finding → CAPA auto-creation) | QMS Tracker |
| §4.2.1 | General documentation requirements — QMS hierarchy | Document hierarchy: QMS Manual → Procedures → Work Instructions → Records | Documents |
| §4.2.3 | Control of documents — approval, review, update, distribution | Version control with mandatory approval workflow; supersession control; controlled distribution list | Documents |
| §4.2.4 | Control of records — legibility, identification, storage, retrieval | WORM-locked record storage; indexed retrieval; role-based access; retention schedule | Documents |
| §5.1 | Management commitment — quality policy, management review | QMS Tracker: quality policy management; management review with attendance and action tracking | QMS Tracker |
| §5.6 | Management review — inputs, outputs, actions | Structured management review template: required inputs (audit results, CAPA status, complaints) and outputs | QMS Tracker |
| §6.2 | Human resources — competence, training, awareness | Training module: competency requirements per role, training plan, completion records | Training |
| §6.3 | Infrastructure — maintenance records | Maintenance log within Travellers module; equipment calibration records | Travellers |
| §7.1 | Planning of product realisation | Project module: device development project planning with QMS document linkages | Projects |
| §7.2 | Customer-related processes — requirement review, communication | CRM: customer requirements capture, review records, complaint management | CRM |
| §7.3 | Design and development — planning, inputs, outputs, review, V&V | DHF: full design control lifecycle from input to validation; design review gate management | DHF |
| §7.3.2 | Design and development planning | DHF project plan with stage gates, responsible parties, and document deliverable requirements | DHF |
| §7.3.3 | Design inputs | Design input records with traceability to regulatory requirements and user needs | DHF |
| §7.3.6 | Design verification | Verification protocol and report management; test result records with approver e-signature | DHF |
| §7.3.7 | Design validation | Clinical/usability validation protocol and report; human factors records | DHF |
| §7.4 | Purchasing — supplier evaluation, selection, monitoring | Supplier qualification: evaluation criteria, scoring, approval, monitoring schedule | Suppliers |
| §7.5.1 | Production and service provision — controlled conditions | Traveller module: step-by-step production instruction sign-off; in-process inspection records | Travellers |
| §7.5.3 | Identification and traceability | Batch/lot tracking in Travellers and Shipments; device identification records | Travellers · Shipments |
| §7.5.8 | Handling, storage, distribution records | Shipments: dispatch records, storage condition records, distribution log | Shipments |
| §7.6 | Control of monitoring and measuring equipment | Calibration records in Travellers; calibration schedule; out-of-calibration CAPA trigger | Travellers · CAPA |
| §8.2.1 | Feedback — customer complaint and post-market data | CRM complaint tracking; trend analysis; MDR report drafting | CRM |
| §8.2.2 | Internal audit | Audit Management: annual schedule, checklist-based audits, findings, closure | Audits |
| §8.3 | Control of non-conforming product | NCR module: identification, segregation flag, disposition decision, CAPA linkage | CAPA & NCR |
| §8.4 | Analysis of data — trends, supplier performance, product conformity | QMS Tracker dashboard: CAPA trend charts, audit finding trends, supplier performance scores | QMS Tracker |
| §8.5 | Improvement — CAPA, preventive action | CAPA module: structured root cause analysis, action planning, effectiveness verification | CAPA & NCR |
The FDA's regulation on electronic records and signatures. Required for any manufacturer selling into the US market or seeking FDA clearance. MDCN Studio covers all 17 applicable sections.
| Section | Requirement | MDCN Studio Coverage | Module |
|---|---|---|---|
| §11.10(a) | Validation of closed systems | System-level validation documentation (IQ/OQ/PQ) maintained by MDCycloNova; available on request | Platform |
| §11.10(b) | Ability to generate accurate copies of records | Export function for all records in PDF; raw data export (CSV/JSON) | All Modules |
| §11.10(c) | Protection of records — accuracy and readiness for inspection | S3 Object Lock WORM storage prevents modification or deletion; immutable record flag on all compliance records | Documents |
| §11.10(d) | Limiting access to authorised individuals | Role-based access control (RBAC); module-level permission gates; session timeout; MFA via Cognito | Users · Teams |
| §11.10(e) | Audit trail — secure, computer-generated, time-stamped | Automatic audit trail for every create/update/delete/approve action; tamper-evident; cannot be disabled | All Modules |
| §11.10(f) | Operational system checks — enforcing event sequencing | Workflow enforcement: documents cannot be approved without review; CAPA cannot close without effectiveness check | Documents · CAPA |
| §11.10(g) | Authority checks — only authorised individuals can sign | Role-based signature authority matrix; configured per document type and record class | Documents · Teams |
| §11.10(h) | Device checks — valid source of data entry | Session-bound authentication; server-side input validation; all inputs logged with session ID | Platform |
| §11.10(i) | Personnel training requirements for system use | System training records; role-based training assignment; mandatory training gate before system access | Training |
| §11.10(j) | Audit trail availability for FDA inspection | Audit trail export function; FDA inspection mode (read-only view of full record history) | All Modules |
| §11.10(k) | Operational controls — documentation of record changes | Every field change logged with: prior value, new value, user ID, timestamp, reason for change | Audit Trail |
| §11.50 | Signature manifestations — name, date/time, meaning | E-signature modal displays: signer printed name, date and time of signature, meaning/purpose | Documents · CAPA |
| §11.70 | Signature/record linking — signatures linked to records | Cryptographic binding of e-signature to specific record version; re-signing required if record modified post-signature | All Signed Records |
| §11.100 | Electronic signatures unique to one individual | Cognito-managed unique user IDs; no shared accounts enforced; account sharing detection | Users |
| §11.100(b) | Electronic signatures not reused or reassigned | User ID retirement on offboarding; retired IDs not reassigned; offboarding audit trail | Users · Teams |
| §11.200(a) | Non-biometric e-signatures — two distinct ID components | Username + password as first component; session-specific signature PIN or re-authentication as second | Auth · E-Signature |
| §11.200(a)(2) | Continued sessions — one component for subsequent signings | Session-bound signature: first signing requires re-authentication; subsequent within session use session token | Auth · E-Signature |
The EU's medical device regulatory framework applicable since May 2021. Annex IX defines quality system requirements for Class IIa, IIb, and III devices. MDCN Studio covers 11 of 12 Annex IX requirements — EUDAMED direct submission API is roadmap Q3 2026.
| Clause | Requirement | MDCN Studio Coverage | Module |
|---|---|---|---|
| Annex IX, 2.1 | Quality management system — organisational structure, responsibilities | QMS Tracker: organisational quality function documentation; management responsibility assignment | QMS Tracker · Teams |
| Annex IX, 2.2 | Resource management — qualified personnel, training | Training module: role qualification records, competency matrix, training history | Training |
| Annex IX, 2.3 | Document and record control | Full document control with version history, approval audit trail, WORM record protection | Documents |
| Annex IX, 2.4 | Clinical evaluation and post-market clinical follow-up | DHF: clinical evaluation document management; post-market surveillance data in CRM | DHF · CRM |
| Annex IX, 2.5 | Vigilance and post-market surveillance | CRM complaint module with EU MDR vigilance report templates; trend analysis | CRM · CAPA |
| Annex IX, 2.6 | Risk management throughout lifecycle | Risk Management: ISO 14971-aligned, linked to DHF and post-market data | Risks |
| Annex IX, 2.7 | Design and development controls | Design History File (DHF): full §7.3 design control lifecycle | DHF |
| Annex IX, 2.8 | Production and service controls | Travellers: production record management; in-process and final inspection records | Travellers |
| Annex IX, 2.9 | Purchasing and supplier controls | Supplier management: qualification, monitoring, incoming inspection | Suppliers |
| Annex IX, 2.10 | Identification and traceability — UDI requirements | Shipments: UDI/batch tracking fields; device identification records. Note: EUDAMED direct API is roadmap Q3 2026 | Shipments |
| Annex IX, 2.11 | Corrective and preventive action | CAPA module: structured CAPA workflow with root cause, action plan, effectiveness verification | CAPA & NCR |
| Annex IX, 2.12 | Improvement — measurement, analysis, improvement processes | QMS Tracker: KPI dashboard, trend analysis, management review inputs | QMS Tracker |
Which MDCN Studio modules satisfy which regulatory frameworks.
| Module | CDSCO MDR 2017 | ISO 13485:2016 | 21 CFR Part 11 | EU MDR 2017/745 |
|---|---|---|---|---|
| DHF | ✓ | ✓ | ✓ | ✓ |
| Documents & SOPs | ✓ | ✓ | ✓ | ✓ |
| CAPA & NCR | ✓ | ✓ | — | ✓ |
| Audits | ✓ | ✓ | ✓ | — |
| Risk Management | — | ✓ | — | ✓ |
| Suppliers | ✓ | ✓ | — | — |
| Training | ✓ | ✓ | — | — |
| Travellers / BHR | ✓ | ✓ | — | — |
| Shipments | ✓ | ✓ | — | ✓ |
| QMS Tracker | ✓ | ✓ | ✓ | ✓ |
| CRM | ✓ | ✓ | — | ✓ |
| User Management | — | ✓ | ✓ | — |
| AI Assistant | ✓ | ✓ | ✓ | ✓ |
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