Masterclass on RAC (Devices) Preparation Strategy on 24th April
RAC (Devices) – Comprehensive Certification Preparation Program
Duration : 20–24 hours
Modules:
- RAC (Devices) Foundations & Exam Orientation
- Global Medical Device Regulatory Foundations
- Domain I – Strategic Planning
- Domain II – Pre-Market
- Domain III – Post-Market
- Domain IV – Interfacing
- Exam Reasoning, Mock Practice & Final Readiness
Features:
- In-depth module handbooks designed for thorough exam preparation
- 700+ practice Q&A questions with detailed explanations across all modules
- Scenario-based exercises to build real regulatory judgment, not just recall
- Full coverage of Strategic Planning (≈29%), Pre-Market (≈25%), Post-Market (≈38%), and Interfacing (≈8%) domains
- Online assessments accessible directly from our LMS
- Exam-focused reasoning strategies including distractor traps and risk-based elimination
- Bonus: 6 downloadable full-length practice tests (100 questions each)
- Companion handbook covering Reimbursement/HTA, Import/Export, and Licensing Maintenance
Note that access to the course will be for 3 months from purchase
₹ 12,000 / USD 145 Only
ISO13485 Medical Device Quality Management System
Duration : 12-14 hours
Modules:
- Why ISO 13485 Exists
- The Three Core QMS Principles
- How Clauses Connect
- Risk-Based Thinking in Practice
- Process Approach Explained
- Turning Compliance into Value
Features:
- Comprehensive video-based learning (8+ hours of content)
- Assignments and quizzes to reinforce understanding
- Live interactive sessions for doubt-solving
- Complete coverage of ISO 13485 QMS fundamentals
- Industry-relevant insights beyond clause memorization
- 3 hours of video lessons
- 9 trainer-assessed assignments
- 51 modules
- Quizzes after each module
Note that access to the course will be for 6 months from purchase
₹ 10,000 Only
Fundamentals of IEC 60601-1: Safety Requirements for Medical Electrical Equipment
Duration : 4 – 4.5 hours
Modules:
- IEC 60601-1 Foundations & the Standard Series
- Key Terminology, Classifications & Essential Concepts
- Electrical Safety Requirements — Design & Testing
- Design Controls & IEC 60601-1 Integration
- Third-Party Testing, Certification & Post-Market
- Emerging Technologies & Future-Ready Compliance
Salient features:
- Expert designed curriculum with Real-World Industry Examples
- Quizzes after each module to test your learning
- Weekly live sessions for clearing doubts
- Learning community for discussions and peer support
Note that access to the course will be for 3 months from purchase
₹6000 ₹ 4000 Only
Foundations of Clinical Evidence for Medical Devices
Modules:
- Introduction to Clinical Evaluation
- CER Structure and Core Principles
- Literature Search Fundamentals
- Literature Appraisal Basics
- Writing the CER Narrative
- Common Pitfalls and Readiness for Advanced Training
This introductory course builds a foundational understanding of how clinical evidence supports regulatory decision-making for medical devices. Learners are introduced to the purpose of clinical evaluation, the role of Clinical Evaluation Reports (CERs), the principles of systematic literature searches and appraisals, and how evidence is translated into defensible regulatory conclusions.
The course focuses on regulatory logic and expectations rather than full execution.
At the end of the course, learners will complete 20 multiple-choice questions to assess their understanding and readiness for advanced CER and literature appraisal training.
Free Course
Fundamentals of Post-Market Surveillance (PMS) of Medical Devices
Duration : 3.5 – 4 hours
Modules:
- PMS Foundations & Regulatory Context
- Designing a PMS System with focus on the EU system
- PMS Data Analysis & Continuous Improvement
- Vigilance, Reporting & Field Actions
- Building a Global PMS Culture
Salient features:
- Expert designed curriculum with Real-World Industry Examples
- Quizzes after each module to test your learning
- Tutor evaluated assignment to reinforce learning
- Downloadable resources for a head-start
- Weekly live sessions for clearing doubts
- Learning community for discussions and peer support
Note that access to the course will be for 3 months from purchase
₹3000 ₹ 1500 Only
Process Validation for Medical Device Manufacturing
Duration: 3.5 – 4 hours
Modules:
- Foundations of process validation
- Planning and Strategy: The Validation Master Plan (VMP)
- Equipment and Process Qualification (IQ, OQ, PQ)
- Maintaining the Validated State
- Allied Concepts (Cleaning Validation, Test Method Validation, Software Validation)
- Documentation and Audit Readiness
Benefits:
- Expert designed curriculum with Real-World Industry Examples
- Quizzes after each module to test your learning
- Tutor evaluated assignment to reinforce learning
- Downloadable resources for a head-start
- Weekly live sessions for clearing doubts
- Learning community for discussions and peer support
Note that access to the course will be for 3 months from purchase
₹3000 ₹ 1500 Only
Computer System Validation (CSV) in Regulated Industries
Duration : 3.5 – 4 hours
Modules:
- Foundations: CSV vs CSA, lifecycle, risk-based approach
- Regulations: 21 CFR Part 11, Annex 11, QSR 820, ISO 13485 & ISO 14971, Data Integrity
(ALCOA+) - Validation Practice: Planning, testing (IQ/OQ/PQ), documentation, supplier qualification
- Modernisation: Agile/DevOps, cloud/SaaS, test automation
- Sustainment: Change control, periodic review, audit readiness
Benefits:
- Expert designed curriculum with Real-World Industry Examples
- Quizzes after each module to test your learning
- Tutor evaluated assignment to reinforce learning
- Downloadable resources for a head-start
- Weekly live sessions for clearing doubts
- Learning community for discussions and peer support
Note that access to the course will be for 3 months from purchase
₹3000 ₹ 1500 Only
Software as a Medical Device (SaMD): Regulatory & Quality Perspectives
Duration : 4 – 4.5 hours
Modules:
- SaMD Foundations & Global Regulatory Context
- U.S. FDA Framework & Digital Health Regulations
- EU MDR Rule 11 Classification & MDCG Guidance
- SaMD Lifecycle, Risk Management & QMS Integration (IEC 62304, ISO 14971)
- AI/ML-Enabled SaMD & FDA’s SPS/ACP Model
- Practical Classification, Documentation & Case Studies
Features:
- Expert-designed curriculum with real-world regulatory examples
- Hands-on classification activities (IMDRF, FDA, EU MDR)
- Practical documentation guidance for 510(k) & EU Technical Files
- Quizzes and tutor-evaluated exercises after each module
- Downloadable resources and templates for quick implementation
- Weekly live sessions for clearing doubts
- Learning community for discussions and peer support
Note that access to the course will be for 3 months from purchase
₹4500 ₹ 1500 Only
Literature Search and Appraisal for Medical Devices
Duration : 6 – 8 hours
Modules:
- Foundations and Regulatory Expectations
- Literature Sources
- Search Strategy
- Selecting Search Databases
- Database Searches and Pubmed Search
- Cochrane Library Search
- ClinicalTrials.gov Search
- Combining Evidence across Databases
- Screening and Minimizing Bias
- Critical Appraisal of Evidence
- Documentation of Search and Appraisal
Features:
- Expert-designed curriculum with real-world regulatory examples
- Quizzes and tutor-evaluated exercises after each module
- Downloadable resources and templates for quick implementation
- Weekly live sessions for clearing doubts
- Learning community for discussions and peer support
Note that access to the course will be for 3 months from purchase
₹6000 ₹ 1500 Only
Design Quality Engineering for Medical Devices
Duration : 6 – 8 hours
Modules:
- Introduction and Regulatory Foundation
- Design & Development Planning
- User Needs & Intended Use
- Design Inputs
- Design Outputs
- Design Verification & Validation
- Design Reviews
- Design Transfer
- Design Changes & Post-Market Integration
- Design History File & Traceability
Features:
- Expert-designed curriculum with real-world regulatory examples
- Quizzes and tutor-evaluated exercises after each module
- Downloadable resources and templates for quick implementation
- Weekly live sessions for clearing doubts
- Learning community for discussions and peer support
Note that access to the course will be for 3 months from purchase
₹5000 ₹ 1500 Only
Medical Device Regulatory Affairs Certificate Program
A complete two-level pathway — from foundational principles to advanced technical competency — for professionals seeking regulatory mastery in the global medical device industry.
Duration: 20 -24 hours
Modules:
Level 1
- Foundations of Medical Device Regulation
- Risk-Based Regulation & Device Classification
- Quality Management Systems (QMS) Fundamentals
- Product Lifecycle, Regulatory Pathways & MDSAP
- Design Controls Fundamentals
- Risk Management Fundamentals (ISO 14971)
- Verification & Validation Basics
- Clinical Evaluation Fundamentals
- Regulatory Documentation & Technical Files
- Change Management & Regulatory Impact
- Post-Market Surveillance & Vigilance
- Working with Regulators & Inspections
Level 2
- Biomaterials & Biocompatibility Testing
- Manufacturing Processes for Medical Devices
- Clean Rooms & Environmental Controls
- Sterilisation Methods & Validation
- Common Test Methods for Medical Devices
- Testing of Electromedical Devices
- Software Medical Devices (SaMD)
- Basics of Clinical Trials
- Design, Process & Packaging Validation
- Test Method Validation & Analytical Methods
- Quality Approaches: QbD, QbT & Hybrid
- Stability & Shelf Life Fundamentals
- Statistical Methods for Medical Device Testing
- Human Factors Engineering & Usability
- Post-Market Surveillance & Vigilance
- Extractables & Leachables (Chemical Safety)
Features:
- Expert-designed curriculum with real-world regulatory examples
- Quizzes and tutor-evaluated exercises after each module
- Weekly live sessions for clearing doubts
- Downloadable Handbook for ready reference
- Learning community for discussions and peer support
Note that access to the course will be for 6 months from purchase
Pre-requisite: Learning will be more effective if you do this course along with the course on Literature Search and Appraisal.
₹ 12000 Only
Writing Effective Clinical Evaluation Reports
Duration : 12-14 hours
Modules (total 40 lessons):
- Introduction and Regulatory Foundation
- Defining Scope and the Clinical Evaluation Plan
- Identification of pertinent data
- Appraisal and Evidence Weighting
- Analysis, benefit-risk and PMCF
- Compiling the CER
- Post-Release and NB Interactions
- Special CER Scenarios
Features:
- Expert-designed curriculum with real-world regulatory examples
- Quizzes and tutor-evaluated exercises after each module
- Downloadable resources and templates for quick implementation
- Weekly live sessions for clearing doubts
- Learning community for discussions and peer support
Note that access to the course will be for 3 months from purchase
Pre-requisite: Learning will be more effective if you do this course along with the course on Literature Search and Appraisal.
₹8000 ₹ 2000 Only
Coming Soon
- Clinical Evaluation of Software Devices
- Regulatory Affairs Fundamentals
- Fundamentals of Medical Device Sterilization
- ISO13485
- EU MDR
- EU IVDR
- EU IVDR
- Risk Management of Medical Devices
- Statistical Process Control
- Measurement System Analysis
- Root Cause Analysis and CAPA
- Design of Experiments
………………… and many others
Ready to Learn?
Whether you’re new to RA/QA and building your foundation, or an experienced professional looking to deepen your expertise, NeuLearn has a path for you.