All Courses & Training Programs
Total Available Programs: 61
ISO 13485 Certified Quality Manager - Medical Devices
A 44-hour training program covering 5 e-courses: ISO 13485 Lead Auditor, ISO 14971 Risk Management, FDA 21 CFR Part 820 QMSR, GDP, and FMEA.
ISO 14971:2019 Risk Management for Medical Devices
Understand the role of risk management in medical devices, practice fundamentals, and interpret ISO 14971 clauses.
U.S. FDA 21 CFR Part 820 QMSR Requirements
Teaches the FDA Quality Management System Regulations (QMSR) required for Medical Devices with a Certificate of Competence.
ISO 13485:2016 Lead Auditor Training Course
Detailed understanding of ISO 13485 QMS requirements and ISO 19011 Lead Auditing principles with Exemplar Global certification.
Good Documentation Practice (GDP) & Data Integrity
Overview of key concepts and major requirements for ISO Good Documentation Practice and Data Integrity (ALCOA).
European Medical Device Regulation (EU) 2017/745 - MDR
Covers significant impacts on QMS, technical requirements, and responsibilities for manufacturers, importers, and distributors.
Understand Requirements for Importers and Distributors under MDR/IVDR
Focuses on obligations for economic operators, storage, transport, and practical fulfilment of MDR/IVDR requirements.
Technical Documentation per MDR (EU) 2017/745
Learn how to present evidence of compliance, structure content, and address factors like classification and intended use.
European In Vitro Diagnostic Device Regulation (EU) 2017/746 - IVDR
Detailed overview of requirements for IVD devices, biological sample testing, classification, and safety profiles under Article 2.
Systematic Literature Review for Medical Devices
Systematic literature review methodology, optimization of search term strategies, evaluation and weighting of clinical data for MDR.
Biocompatibility of Medical Devices (ISO 10993)
Covers software safety/effectiveness compliance and main steps for ensuring biocompatibility specified in ISO 10993-1 standard.
ISO 22301 Certified Manager - Business Continuity
A 42-hour program covering ISO 22301 Lead Auditor, ISO 31000 Risk Management Guidelines, GDP, and FMEA.
ISO 22301:2019 Lead Auditor Training
Teaches detailed requirements of ISO 22301 Business Continuity Management Systems and ISO 19011 Auditing.
ISO 22301 Training Bundle (Auditor + Risk + FMEA)
Includes ISO 22301 Internal Auditor, ISO 31000 Risk Management, and Failure Mode & Effects Analysis (FMEA).
AI Risk Management & Governance Training
Combines theoretical AI risk governance (NIST / EU AI Act) with practical scenarios, evaluation, monitoring, and certification exam.
Medical Device Single Audit Program (MDSAP) for Manufacturers
Understand the MDSAP framework that allows a single audit to satisfy regulatory requirements across multiple countries.
Know and Implement the Regulatory Requirements of MDSAP Program Countries
Detailed walkthrough of country-specific regulatory requirements within the MDSAP program (US, Canada, Australia, Brazil, Japan).
Analyze US Requirements (21 CFR Part 820) - Quality System Compliance
In-depth two-day workshop analyzing FDA Quality System Compliance requirements under 21 CFR Part 820.
Prepare Your Application for the US Market (510k, De NOVO, or PMA)
Practical guidance on preparing and submitting 510(k), De Novo, or PMA applications for FDA market clearance.
Analyze Canadian Requirements - Medical Devices Regulations (SOR/98-282)
One-day overview of Canadian Medical Devices Regulations (SOR/98-282) and licensing requirements.
Technical Documentation per IVDR (EU) 2017/746
Learn to structure and prepare technical documentation files required under the EU IVDR 2017/746 regulation.
Understand Requirements for Devices in Annex XVI of MDR
Covers regulatory requirements for products without an intended medical purpose listed under MDR Annex XVI.
Understand Combination Products Requirements (Article 117 of MDR)
Examines regulatory pathways and requirements for drug-device combination products under MDR Article 117.
Analyze the Role of the PRRC (Person Responsible for Regulatory Compliance)
Clarifies the responsibilities, qualifications, and legal accountability of the PRRC role required under MDR/IVDR.
Understand Requirements for Importers and Distributors under MDR/IVDR
Broader coverage of importer and distributor obligations across both MDR and IVDR regulations.
Identify Regulatory and Legal Responsibilities According to Your Role
Maps out regulatory and legal obligations for each economic operator role in the medical device supply chain.
Advertising of Medical Devices
Covers the regulatory rules and restrictions governing the advertising and promotion of medical devices.
ISO 13485:2016 Requirements
Foundational two-day course covering the core requirements of the ISO 13485:2016 quality management standard.
Adapting Your QMS to ISO 9001:2015 Standard
Guidance on aligning an existing quality management system with the ISO 9001:2015 requirements.
Internal Audit and Supplier Audit for Medical Device Manufacturers
Practical training on planning and conducting internal and supplier audits within a medical device QMS.
Managing Subcontractors and Suppliers in Accordance with ISO 13485
Covers supplier qualification, monitoring, and control requirements defined by ISO 13485.
Design a Medical Device in Accordance with ISO 13485 Requirements
Walks through the design control process for medical devices as required by ISO 13485.
Auditing MDR Requirements Against ISO 13485
Advanced two-day course on cross-referencing and auditing MDR requirements within an ISO 13485 QMS.
Managing Problems and Non-Conformities to Improve Performance
Two-day course on root cause analysis, CAPA, and non-conformity management to drive continuous improvement.
Using Statistical Tools in the Application of ISO 13485
Introduces key statistical tools and techniques used to support ISO 13485 quality processes.
Medical Device Software Lifecycle per IEC 62304
Covers the software development lifecycle requirements for medical device software under IEC 62304.
Validate Software Tools Used in the Quality Management System
Practical approach to validating software tools that support quality management system processes.
Implementation of Risk Management Process per ISO 14971
Hands-on 1.5-day workshop focused on implementing the ISO 14971 risk management process in practice.
Compiling a File on Usability Engineering of Medical Devices
Teaches how to compile a complete usability engineering file to support medical device submissions.
Clinical Investigation of Medical Devices
Two-day course covering the planning, conduct, and reporting of clinical investigations for medical devices.
The Clinical Evaluation Report (CER) Requirements Under EU MDR
Focuses on structuring and preparing the Clinical Evaluation Report required under EU MDR.
Perform Performance Evaluation and Clinical Evidence Assessment for IVDs
Covers performance evaluation methodology and clinical evidence assessment specific to IVD devices.
Radiation Sterilization of Medical Devices
Two-day course on radiation sterilization methods, dose validation, and process control for medical devices.
Sterilization of Medical Devices Using Ethylene Oxide
Covers process validation and control requirements for ethylene oxide sterilization of medical devices.
Moist Heat Sterilization - Process Validation and Control
Detailed two-day training on validating and controlling moist heat (steam) sterilization processes.
Atypical Sterilization of Medical Devices
Explores alternative and emerging sterilization methods beyond the standard techniques.
Microbiology of Medical Devices and Clean Room Working Environment
Two-day course covering microbiological controls and clean room practices in medical device manufacturing.
Aseptic Processing of Healthcare Products
One-day overview of aseptic processing principles and controls for healthcare products.
Cleanliness of Newly Manufactured Medical Devices
Covers cleanliness requirements and testing methods for newly manufactured medical devices.
Reprocessing of Reusable Medical Devices
Two-day course on validating cleaning, disinfection, and sterilization processes for reusable medical devices.
Validate Medical Device Manufacturing Processes (IQ/OQ/PQ)
Two-day course on installation, operational, and performance qualification for manufacturing processes.
Mastering Statistical Process Data (SPC/MSP)
Two-day hands-on training on statistical process control and measurement system analysis techniques.
Packaging Materials and Systems for Terminally Sterilized Medical Devices
Covers packaging validation requirements for terminally sterilized medical devices.
Electrical Safety & Electromagnetic Compatibility (EMC) for Medical Devices
Comprehensive training on electrical safety principles, IEC 60601-1 requirements, risk management integration, and EMC testing for electromedical devices.
Post Market Surveillance and Vigilance
One-day overview of post-market surveillance and vigilance obligations for medical device manufacturers.
Vigilance in Europe and Internationally - Incident Management
Two-day course on managing vigilance incidents and reporting obligations across European and international markets.
Implementing UDI (Unique Device Identifier) Requirements
One-day practical course on implementing Unique Device Identifier (UDI) labeling and database requirements.
Biocompatibility of Medical Devices (ISO 10993)
Two-day course dedicated to biocompatibility evaluation requirements under the ISO 10993 series.
Medical Devices Incorporating Materials of Animal Origin (DMOA)
Covers regulatory and risk requirements for medical devices containing materials of animal origin.
Responding to FDA Pre-Market Cybersecurity Guidance
One-day course on addressing FDA cybersecurity expectations in pre-market medical device submissions.
Designing and Facilitating Engaging Training
Two-day train-the-trainer course on designing engaging content and facilitating effective training sessions.