Free guides for Indian medical device manufacturers navigating CDSCO MDR 2017, ISO 13485, FDA 21 CFR Part 11, and EU MDR. No sign-up required — just email us for the full document.
A practical checklist covering all 12 Schedule 5 QMS requirements for CDSCO-licensed manufacturers. Includes what documentation you need, what CDSCO inspectors look for during Form 34B inspections, and how to build a traceable audit trail using your existing SOPs.
Covers: Document control · Training records · CAPA evidence · NCR disposition · Internal audit findings · Management review
Get Free Guide →A step-by-step guide for manufacturers beginning their ISO 13485:2016 certification journey. Covers the gap analysis process, which sections (4–8) require the most documentation effort, how to run your first internal audit, and what a certification body assessor will examine on day one.
Covers: Sections 4–8 overview · Document hierarchy · Design controls (§7.3) · CAPA workflow (§8.5) · Internal audit checklist
Get Free Guide →A plain-language overview of FDA's electronic records and e-signature regulation. Explains which sections (§11.10, §11.50, §11.70, §11.100, §11.200) apply to your QMS, what an FDA inspector will ask for during a 483 inspection, and how e-signature systems must be configured to be compliant.
Covers: Audit trail requirements · E-signature manifestations · Access control · System validation · Closed system controls
Get Free Guide →Based on common CDSCO and ISO 13485 audit findings related to Design History Files. Covers the most common DHF gaps auditors flag, how to structure your DHF index, what traceability means in practice (from user need to validation evidence), and how to make a DHF package auditor-ready in one week.
Covers: DHF structure · Design input/output linkage · Verification vs. validation · Risk file integration · Common CDSCO Form MD-3 failures
Get Free Guide →Supplier qualification is one of the most common ISO 13485 non-conformances found during audits. This guide explains how to build an approved vendor list, what a supplier qualification checklist must include, how to handle critical supplier audits, and what incoming inspection records must document.
Covers: Approved vendor list · Supplier qualification criteria · Supplier audit checklist · Incoming inspection records · Supplier performance monitoring
Get Free Guide →A practical walkthrough of the full CAPA lifecycle — from capturing a non-conformance to closing the CAPA with a verified effectiveness review. Includes root cause analysis methods (5 Whys, Fishbone, 8D), how to write an action plan that satisfies ISO 13485 §8.5.2, and what effectiveness verification evidence auditors expect.
Covers: NCR to CAPA workflow · Root cause methods · Action plan structure · Effectiveness review criteria · CAPA closure sign-off
Get Free Guide →A quick reference for the four regulatory frameworks MDCN Studio covers — and who needs each one.
Every manufacturer operating under CDSCO regulations with a manufacturing licence. Schedule 5 defines the QMS requirements.
QMS manual · SOPs · Training records · CAPA log · Audit reports · NCR register · Management review minutes
Manufacturers seeking ISO 13485 certification (required for EU CE marking and preferred by US distributors). Covers Sections 4–8 of the standard.
Quality manual · DHF · CAPA records · Supplier qualification · Internal audit reports · Competency records · Design review minutes
Manufacturers selling into the US market or seeking FDA 510(k) clearance. Applies to any electronic records or electronic signatures used in compliance workflows.
Immutable audit trail · E-signature with printed name + date + meaning · WORM record storage · Access controls · System validation documentation
Manufacturers exporting Class I, IIa, IIb, or III devices to the European Union. CE marking requires compliance with Annex IX quality system requirements.
Technical documentation (Annex II) · Clinical evaluation report · Risk management file (ISO 14971) · Post-market surveillance plan · UDI registration