Medical device courses by topic
Find your next MedTech course with ease. Browse upcoming courses structured by topic – tailored to professionals working with medical devices.
Whether you're navigating global regulations, preparing for audits, developing new products, or handling sensitive health data – MedTech Academy has the right course for you.
This page gives you an overview of all upcoming courses, organised by topic. Each category reflects the most current industry needs and links to detailed course descriptions, dates, and registration.
All courses are designed for professionals working in or with the medical device industry – including Regulatory Affairs, Quality Assurance, R&D, Marketing, Consultants and more.
Auditing
Audits are a critical part of quality assurance and regulatory compliance in the medical device sector. Whether you’re preparing for an internal audit, meeting ISO 13485 or MDSAP requirements, or handling CAPA processes, you need the right tools and methods to succeed.
Our auditing courses are tailored to quality managers, regulatory professionals and internal auditors seeking practical skills for planning, conducting, and responding to audits. Topics range from international audit frameworks to root cause analysis and preventive actions.
Internal auditing & ISO 13485
Gain the skills to lead or support internal audits in compliance with ISO 13485 and other relevant standards. Ideal for professionals working with QMS and quality documentation.
IRCA Certified ISO 13485:2016 QMS Lead Auditor Training for Medical Devices
Achieve IRCA certification and master the full audit cycle for ISO 13485:2016 – from planning to reporting.
ISO 13485 and Quality Management for Medical Devices / Internal Auditing
Learn how to perform effective internal audits and support quality assurance under ISO 13485.
Training of internal auditors in relation to country specific requirements within the MDSAP program
Understand the structure and requirements of MDSAP and prepare to audit across multiple jurisdictions.
MDR & CAPA focus
These courses help you handle specific auditing challenges – including EU MDR requirements and how to manage corrective and preventive actions efficiently.
Corrective & Preventive Actions (CAPA)
Strengthen your CAPA process with tools for identifying root causes and implementing lasting improvements.
MDR Auditing – Training of Internal Auditors in Relation to MDR
Build competence in internal auditing under MDR, including how to document findings and handle notified body expectations.
Biocompatibility
Biocompatibility is a fundamental requirement for medical devices that come into contact with the human body. Understanding how materials interact with biological systems throughout the product’s lifecycle is essential for ensuring safety, regulatory approval and patient trust.
These courses provide in-depth knowledge on evaluating materials, assessing risk, and documenting biocompatibility in line with international standards. You'll gain practical tools for lifecycle assessment, shelf life evaluation, and polymer material analysis from a safety perspective.
Biological safety & material risk
Learn how to assess and document biocompatibility risks across device development – including long-term effects, degradation, and material interactions over time.
Evaluation of Biocompatibility over the Whole Life Cycle with Focus on Shelf Life
Understand how to evaluate biological risks throughout a device’s lifecycle – with special focus on the impact of aging and shelf life.
Introduction to Polymer Materials in Medical Devices – from a Biocompatibility Risk Perspective
Gain insight into polymer materials and their biological interactions in medical devices, with tools to assess risk and ensure safety.
Clinical evaluation
Clinical evaluation is a key regulatory requirement for demonstrating the safety and performance of medical devices. Whether you're preparing clinical evidence under MDR or planning a global strategy, it's essential to understand the latest expectations and methods.
Our courses cover both the regulatory and strategic dimensions of clinical evaluation. You’ll learn how to design clinical evaluation plans, interpret data, and link findings to market access – including the role of reimbursement strategies in shaping your clinical approach.
Clinical evidence & evaluation
Get up to speed with European and international expectations for clinical evaluations – from planning and documentation to regulatory submission and post-market updates.
Clinical Evaluation for Medical Devices in Europe and International Approach
Gain a clear understanding of clinical evaluation requirements in both Europe and international markets. The course covers the full process – from planning and documentation to regulatory submission and post-market updates.
Reimbursement strategy
Understand how reimbursement policies influence clinical strategies and evidence generation. Ideal for those working at the intersection of regulatory, market access, and health economics.
Reimbursement as a Driver for Commercial and Clinical Strategies
Learn how reimbursement policies shape clinical strategies and evidence generation. Ideal for professionals working at the intersection of regulatory affairs, market access, and health economics.
Cybersecurity
As medical devices become increasingly connected, cybersecurity is no longer optional – it's a regulatory and ethical imperative. Threats to data integrity, patient safety and system functionality must be identified and mitigated from the earliest design phases.
This course gives you practical tools to analyse risks, design secure architectures and implement effective security controls. Learn how to model threats and defend against vulnerabilities specific to medical technologies.
Security architecture & threat modelling
Build secure MedTech systems from the start. Learn how to identify security risks, structure threat models, and design system architectures that defend against vulnerabilities in connected medical technologies.
Threat Modelling, Security Architecture and Controls for Medical Devices: Attacking and Defending
Gain hands-on tools to assess security risks and protect connected medical devices. The course teaches you how to model threats, design secure system architectures, and implement effective cybersecurity controls.
GDPR and data protection
Handling personal data in the medical device industry requires strict compliance with the GDPR and sector-specific regulations. From clinical trials to marketing and customer interactions, data protection must be integrated into every workflow and system.
These courses provide practical and legal insight into how to process, document, and secure personal data in MedTech contexts. Learn to assess legal basis, draft data processing agreements, and understand the rules on consent, advertising and financial relationships.
Advertising and financial transparency
Learn how to communicate responsibly about medical devices while complying with rules on advertising and financial transparency. These courses cover both the grey areas of promotion and the requirements for collaborations with healthcare professionals.
Rules on Advertising, Affiliations and Financial Incentives
Understand the legal framework for advertising and financial transparency in the MedTech industry. The course addresses both promotional grey areas and the rules governing collaborations with healthcare professionals.
Personal data and GDPR compliance
Get to grips with data protection rules in the MedTech industry. These courses give you legal and practical insight into how to comply with the GDPR at every stage – from clinical studies and marketing to data processing agreements and consent.
Handling Personal Data in MedTech – Legal and Practical Challenges
Navigate GDPR compliance with confidence – from clinical trials and marketing to consent and data processing agreements. The course offers legal guidance and practical tools tailored to the medical device sector.
Market access
Getting a medical device to market involves more than compliance – it requires a deep understanding of international regulations, local systems, and market-specific entry requirements. Whether you're navigating UDI, tender law, or health system structures, your success depends on regulatory insight and strategic planning.
These courses are designed for professionals working with registration, labeling, reimbursement, digital marketing, and public tenders. You’ll learn how to align product strategy with complex market conditions across the EU, US, China and Denmark.
Digital communication & compliance
Learn how to navigate the regulatory landscape of digital communication – from websites and social media to professional platforms – in compliance with MedTech promotion rules.
Digital Marketing of Medical Devices
Learn how to navigate the rules and grey areas of digital marketing – from websites and social media to professional platforms – in compliance with MedTech regulations.
Global regulations & market entry
Explore regulatory systems across key markets – including the US, China and Europe – and understand what it takes to gain and maintain market access globally.
New update on China NMPA Regulation and Registration for Medical Devices with Case Studies
Understand the latest Chinese regulatory requirements and how to achieve market access – with real-world case studies from the MedTech industry.
The New US Quality Management System Regulation (QMSR) and other US Regulations for Medical Devices
Get an overview of the updated US regulations for quality systems and medical devices – and how they affect your compliance and market strategy.
Labeling & identification
Understand how to apply and implement Unique Device Identification (UDI) in compliance with regulatory requirements – essential for traceability and global market access.
Introduction to UDI (Unique Device Identification) – Identification and Labelling of Medical Devices
Learn how to implement UDI and labelling in line with global regulatory requirements – essential for traceability and international market access.
Tenders & health systems
Build knowledge of healthcare systems and the tender process to succeed in public procurement and reimbursement-driven markets.
Introduction to the Danish Tender Act
Gain insight into the key principles of the Danish public procurement law and learn how to submit successful bids in healthcare tenders.
Understanding Healthcare Systems & Market Access
Build your understanding of healthcare systems and how they shape market access and reimbursement – in Denmark and key international markets.
MedTech fundamentals
New to the MedTech industry or working in a cross-functional role? A solid understanding of the basics is key to succeeding in product development, regulatory affairs, marketing, and beyond. These foundational courses give you the terminology, context, and practical insight to navigate the industry with confidence.
Whether you're learning about UDI, anatomy, or infection control, these courses provide a clear starting point for professionals entering or supporting the medical device field.
Anatomy & infection control
Understand how the human body works – and how to protect it. These courses introduce essential anatomy and pathology concepts as well as practical infection control for those handling medical devices in clinical or technical settings.
Anatomy, Physiology and Pathology for MedTech
Gain a foundational understanding of anatomy, physiology, and pathology – with a focus on how the human body interacts with medical devices.
Personal Protection for Technicians – Breaking Infection Chains
Learn how to protect yourself and others in clinical or technical settings. This course covers infection prevention and the correct use of personal protective equipment.
MedTech basics & industry overview
Get to know the structure, terminology and key players of the MedTech industry. This course gives newcomers a clear overview of how products move from idea to market – and the rules that shape the journey.
Introduction to the MedTech Industry
Get a clear overview of how the MedTech industry works – including key terminology, product development stages, and regulatory frameworks.
UDI – Unique Device Identification
Learn how to implement and apply UDI for medical devices. These courses explain why traceability matters and how UDI requirements affect labelling, packaging, and compliance in different markets.
Introduction to UDI (Unique Device Identification) – Identification and Labelling of Medical Devices
Understand how to apply UDI in practice. This course explains the importance of traceability and how UDI impacts labelling and compliance in different markets.
Process validation and documentation
Process validation is essential to ensure that medical devices are manufactured consistently and meet defined specifications. It supports regulatory compliance, risk reduction, and quality assurance throughout production and sterilization processes.
These courses give you the tools to plan, execute and document process validation activities – including statistical methods, sterilization validation, and regulatory expectations for manufacturing environments.
Process validation and documentation
Sterilization validation
Gain insight into the principles, documentation and regulatory expectations for industrial sterilization of medical devices.
Industrial Sterilization of Medical Devices – An Introduction to the Practical Approach of Sterilization
Gain a practical understanding of industrial sterilization validation. The course covers documentation requirements, method selection, and regulatory expectations.
Validation planning & execution
Develop and document validation strategies in line with ISO standards and GMP. Learn how to structure validation protocols and apply them across processes.
Process Validation
Learn how to plan and execute process validation to ensure stable and compliant manufacturing conditions. The course focuses on regulatory requirements and hands-on documentation practices.
Statistics for Process Validation
Understand the statistical methods used in process validation. The course introduces relevant analysis techniques and data handling required for regulatory documentation.
Product development and production
Developing safe and effective medical devices requires a structured approach to design, documentation, and risk management. From the first project brief to final documentation, every step must meet strict regulatory and quality standards.
Our courses in product development and production equip you with essential tools and methods to ensure compliance and efficiency. You’ll gain practical insights into project management, risk analysis, design control, and technical documentation – all tailored to the specific needs of the MedTech industry.
Product development and manufacturing
Design control & risk management
Ensure safe and well-documented device design through risk-based approaches. Learn how to apply design control and conduct practical risk analysis throughout the development process.
Design Control
Learn how to structure and document the design process in compliance with regulatory requirements. The course covers key principles of design control with a focus on real-world MedTech examples.
Practical Risk Analysis in Product Development
Gain practical skills in identifying, evaluating, and mitigating risks during product development. The course is ideal for professionals working with safety-critical design processes.
Project management & documentation
Plan and manage device development projects in compliance with regulatory demands. These courses support you in building robust project structures and documentation for safe, timely and compliant market access.
Project Management for Product Development of Medical Devices
Learn how to lead product development projects within the regulatory framework. The course covers planning, stakeholder communication, and practical tools tailored to MedTech innovation.
Technical Documentation for Medical Devices
Understand the structure, content, and regulatory requirements of technical documentation. This course helps you compile compliant and audit-ready documentation for medical devices.
Regulatory compliance
Regulatory compliance is the backbone of safe, effective and market-ready medical devices. Whether you're navigating MDR and IVDR in Europe, understanding FDA and QMSR requirements in the US, or aligning with MDSAP, post-market obligations, or Chinese NMPA guidelines – up-to-date knowledge is essential.
Our regulatory compliance courses give you practical tools to stay ahead of legislation, prepare for audits, and document your processes. You’ll gain insights into roles and responsibilities, technical documentation, combination products, PMS, and more.
All courses are taught by leading experts and designed for professionals working in Regulatory Affairs, Quality Assurance, clinical development, and product compliance in the medical device industry.
Documentation, quality & post-market
Focus on technical documentation, quality systems, combination products, and post-market surveillance – critical elements in maintaining compliance.
Combination Products – Regulatory & Quality Introduction
Understand how combination products are regulated and how to meet quality requirements across product types.
IRCA Certified ISO 13485:2016 QMS Lead Auditor Training for Medical Devices
Train to become a certified lead auditor under ISO 13485. The course prepares you for planning, conducting, and reporting audits of quality systems.
MDSAP Fundamentals and Readiness Training
Gain a structured introduction to MDSAP and what it means for your audit readiness, documentation, and compliance approach.
Planning an Effective Post Market Surveillance Program for Medical Devices and Combination Products
Learn how to plan, structure and document PMS programs in line with MDR and FDA expectations – including combination products.
Technical Documentation for Medical Devices
Understand how to structure and maintain compliant technical documentation for medical devices under MDR and international frameworks.
International regulation & market access
Stay updated on global compliance frameworks including US FDA, QMSR, MDSAP, and Chinese NMPA – essential for companies working across borders.
FDA Regulation of Medical Devices: Recent FDA Guidance Documents
Get updated on the latest FDA guidance and how it affects your submissions, audits, and market access in the US.
New update on China NMPA Regulation and Registration for Medical Devices with Case Studies
Learn how to navigate Chinese regulatory requirements and NMPA registration – including practical case studies.
The New US Quality Management System Regulation (QMSR) and other US Regulations for Medical Devices
Understand the impact of QMSR and other US regulations on your quality system and documentation strategy.
MDR & IVDR
Understand the core EU regulations for medical devices, including the role of the PRRC, audit readiness, and notified body expectations under MDR and IVDR.
The European Approval System for Medical Devices under MDR and IVDR
Get a clear overview of the European regulatory system – including notified bodies, conformity assessment, and documentation routes.
Introduction to MDR (2017/745)
Gain a practical introduction to MDR – including scope, classification, key roles, and transition from MDD.
MDR Auditing – Training of Internal Auditors in Relation to MDR
Learn how to plan and conduct internal audits under MDR. The course focuses on practical audit skills and common findings.
Person Responsible for Regulatory Compliance according to MDR and IVDR
Understand the responsibilities, qualifications and regulatory expectations of the PRRC role under MDR and IVDR.
Software and usability
Software plays an increasingly central role in modern medical devices – whether embedded, standalone, or as part of a connected system. Ensuring software safety, usability, and regulatory compliance is critical throughout the lifecycle.
These courses give you the skills to work with standards such as IEC 62304 and IEC 60601, design user-friendly and safe interfaces, and manage software as a medical device (SaMD) in line with regulatory expectations.
Software standards & lifecycle management
Learn how to apply key international standards to ensure safe and compliant development, testing and maintenance of medical device software.
IEC 60601 – How to Apply Safety and Risk Management to Medical Electrical Equipment and Systems
Understand how to apply IEC 60601 to ensure safety and risk management in the development and use of medical electrical equipment and systems.
IEC 62304: Software Lifecycle
Get to grips with the entire lifecycle of medical device software. Learn how to use IEC 62304 to guide development, testing and maintenance.
Software as Medical Device and Quality Management
Gain insight into managing software as a medical device (SaMD) and meeting regulatory requirements for quality systems and documentation.
Usability in medical device software
Design software interfaces that support patient safety and reduce risk. Learn to align usability with regulatory requirements and real-world clinical use.
Medical Device Usability
Design user-friendly software that supports patient safety. This course helps you align usability engineering with real-world use and compliance standards.
Sustainability
Sustainability is an increasing requirement for medical devices and packaging. Companies must document responsibility throughout the entire product life cycle – from design and material selection to waste management and circular economy. It is about regulatory requirements, environmental considerations and customer trust.
The course provides knowledge of producer responsibility, packaging design and sustainable strategies that combine compliance with the green transition. You will gain practical tools to work with life cycle assessment, documentation and the integration of sustainability in MedTech development.
Packaging design
Producer responsibility for packaging with focus on design
Design user-friendly software that supports patient safety. This course helps you align usability engineering with real-world use and compliance standards.
All topics in medical devices
Explore our topic pages and find the course area that matches your needs:
