Downloadable resources

Free open-source guidelines & SkillMed PDFs

Curated official guideline links from IMDRF, EU MDR/MDCG, Indian MDR/CDSCO, US FDA, ISO/IEC and WHO — plus printable PDF copies of every SkillMed course.

Open source

Free open-source guidelines

Curated links to original regulatory texts and guidance from IMDRF, GHTF, EU MDR/MDCG, Indian MDR/CDSCO, US FDA, ISO/IEC and WHO. All free to download from the issuer's official portal.

IMDRF

International Medical Device Regulators Forum — global convergence guidance, all free to download.

IMDRF final documents library
Master index of all published IMDRF technical documents and working group outputs.
Webpage
Open
Essential Principles of Safety and Performance
Harmonised baseline requirements for medical devices and IVDs.
PDF
2023
Open
Software as a Medical Device (SaMD) framework
Key definitions, risk categorisation and QMS expectations for SaMD.
PDF
Open
UDI guidance
Unique Device Identification system principles for global adoption.
PDF
Open

GHTF (legacy)

Global Harmonization Task Force final documents — superseded by IMDRF but still widely referenced.

GHTF archive (Study Groups 1–5)
Classification, labelling, QMS, clinical evidence and auditing final documents.
Webpage
Open

EU MDR / IVDR / MDCG

European Commission — regulations and MDCG guidance for medical devices and IVDs.

Regulation (EU) 2017/745 — MDR (consolidated)
Full consolidated text of the Medical Device Regulation.
Webpage
Open
Regulation (EU) 2017/746 — IVDR (consolidated)
Full consolidated text of the In Vitro Diagnostic Regulation.
Webpage
Open
MDCG guidance index
All Medical Device Coordination Group guidance — classification, clinical, PMS, UDI, EUDAMED.
Webpage
Open
EUDAMED public portal
European database on medical devices — actors, UDI/devices and certificates modules.
Webpage
Open

Indian MDR / CDSCO

Central Drugs Standard Control Organisation — India's regulator for medical devices.

Medical Devices Rules, 2017 (consolidated)
Principal rules governing medical devices in India, with amendments.
Webpage
Open

US FDA / CDRH

US Food and Drug Administration — Center for Devices and Radiological Health.

21 CFR Part 820 — Quality System Regulation / QMSR
Current QSR text and the 2026 QMSR amendment harmonising with ISO 13485.
Webpage
Open
21 CFR Part 803 — Medical Device Reporting
MDR requirements for manufacturers, importers and user facilities.
Webpage
Open
De Novo classification process
Pathway for novel low-to-moderate risk devices.
Webpage
Open
Cybersecurity in Medical Devices (premarket)
Quality system considerations and content of premarket cybersecurity submissions.
PDF
Open

ISO / IEC reference

Official overview pages for key standards. Full standards are paid — overviews are free.

ISO 13485:2016 — QMS for medical devices
ISO overview page with scope and revision status.
Webpage
Open
ISO 14971:2019 — Risk management
ISO overview for application of risk management to medical devices.
Webpage
Open
ISO 14155:2020 — Clinical investigation
Good clinical practice for clinical investigation of medical devices.
Webpage
Open
IEC 62304 — Medical device software lifecycle
Software lifecycle processes for medical device software.
Webpage
Open
IEC 62366-1 — Usability engineering
Application of usability engineering to medical devices.
Webpage
Open
ISO 10993-1 — Biological evaluation
Evaluation and testing within a risk management process.
Webpage
Open

WHO & other regulators

Global health body and major national regulators.

WHO Global Model Regulatory Framework
WHO model framework for medical devices including IVDs.
PDF
Open
PIC/S GMP guides
Pharmaceutical Inspection Co-operation Scheme — GMP guides and annexes.
Webpage
Open
Australia TGA — medical devices
Therapeutic Goods Administration guidance and forms.
Webpage
Open
Health Canada — medical devices
Canadian Medical Devices Regulations and guidance.
Webpage
Open
Japan PMDA — medical devices
Pharmaceuticals and Medical Devices Agency English portal.
Webpage
Open
Brazil ANVISA — medical devices
ANVISA portal for medical device regulation in Brazil.
Webpage
Open
China NMPA — medical devices (English)
National Medical Products Administration English information.
Webpage
Open

Links point to third-party official portals. SkillMed does not host these documents; availability and revisions are controlled by the issuer. Spotted a broken link? Email info@skillmed.in.

SkillMed PDFs

Training material as PDF

Grab a complete copy of every module in a course as a single PDF — read offline, print for a classroom, or share with your team. For certification, please complete the modules and exam inside the portal.

Medical Device Fundamentals
15 modules
The essentials every medical device professional must know
An introductory course covering what a medical device is, how it is classified in the EU, US and India, the full product life-cycle, the roles and responsibilities of every player in the industry, and the terminology used across standards and regulations.
Open
ISO 13485:2016 - Quality Management System for Medical Devices
20 modules
Quality Management Systems for Medical Devices
The international QMS standard for medical device organisations. Covers scope, documentation, management responsibility, resources, product realisation, and measurement & improvement — clause by clause.
Open
EU MDR — Regulation (EU) 2017/745
20 modules
Placing medical devices on the EU market
The European Union's Medical Devices Regulation. Covers economic-operator obligations, classification, GSPRs, clinical evaluation and PMCF, post-market surveillance, vigilance, UDI and EUDAMED.
Open
ISO 14971:2019 - Risk Management Medical Devices
20 modules
Application of risk management to medical devices
The harmonised risk management standard. Covers terminology, the risk management process, risk analysis and evaluation, risk control, residual-risk and benefit-risk analysis, and production/post-production information.
Open
21 CFR Part 820 — QMSR
20 modules
FDA Quality Management System Regulation
The amended Part 820 incorporates ISO 13485:2016 by reference and replaces the QSR from 2 February 2026. Covers the structure of the QMSR, key differences vs. ISO 13485, and how to transition a QSR system.
Open
Indian MDR — Medical Devices Rules, 2017
20 modules
CDSCO licensing, classification, vigilance & post-market for India
India's Medical Devices Rules, 2017 (effective 1 January 2018). Covers risk classification, CDSCO/SLA licensing forms (MD-5, MD-9, MD-15, MD-42), Fifth Schedule QMS, labelling, clinical investigation, MvPI vigilance, recalls, IVDs and recent amendments.
Open
Regulatory Affairs Mastery
17 modules
Flagship 40–50 hour self-paced regulatory affairs program
A beginner-to-advanced regulatory affairs program covering EU MDR, US FDA, India MDR, ISO standards, technical documentation, clinical evaluation, risk management, labelling & UDI, post-market surveillance, AI/SaMD, audits, real industry case studies and career mastery — across 17 in-depth modules and ~150–200 lessons.
Open
Medical Device Packaging Validation — A Complete Guide
10 modules
ISO 11607-1/-2, seal integrity, ageing, transport and audit-ready files
A complete 10-module guide to medical device packaging validation covering ISO 11607-1 (materials and SBS design), ISO 11607-2 (IQ/OQ/PQ), seal integrity and strength (ASTM F88, F1929, F1140, F2096), sterilisation compatibility, distribution simulation (ASTM D4169, ISTA), accelerated and real-time ageing (ASTM F1980), labelling and UDI, packaging risk management and CAPA, and regulatory submissions.
Open

PDFs are generated on your device from the latest course content. For questions or bulk/branded copies, email info@skillmed.in.

Free open-source guidelines & SkillMed PDFs