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Get certified in medical device regulations and quality management systems
Master Quality System Regulation (QSR) for medical device manufacturing and compliance.
Navigate the complex European Medical Device Regulation and In Vitro Diagnostic Regulation.
Learn to prepare and submit FDA premarket notifications and applications.
Implement risk management processes throughout the product lifecycle.
Understand regulatory requirements in key markets including Asia, Latin America, and MENA.
One-on-one guidance from experienced regulatory affairs professionals.
Learn regulations for all medical device classifications
High-risk devices (implants, life-support)
Moderate-risk devices (infusion pumps, ventilators)
Low-risk devices (bandages, manual instruments)
In Vitro Diagnostic Devices
SaMD (Software as a Medical Device)
Artificial Intelligence & Machine Learning
Dental devices and materials
Ophthalmic devices and implants
12-week program with hands-on writing projects and feedback sessions
Global regulatory landscape, classification systems, regulatory pathway
Establishing and maintaining compliant QMS, audit preparation
Medical Device Reporting, Corrections & Removals, Registration & Listing, QSR
Risk analysis, evaluation, control, and post-production monitoring
Technical documentation, clinical evaluation, Notified Body interactions
Preparing for and managing MDSAP audits across five regulatory authorities
Clinical evaluation reports (CER), clinical investigation planning and execution
Vigilance reporting, post-market clinical follow-up (PMCF), trend reporting
Preparing traditional, special, and abbreviated 510(k) submissions
PMA application preparation, clinical data requirements, panel reviews
Creating technical files and design dossiers for EU MDR compliance
Global submission planning, regulatory intelligence, lifecycle management
FDA software guidance, IEC 62304, cybersecurity requirements
Drug-device, biologic-device combinations, primary mode of action determination
China NMPA, Brazil ANVISA, India CDSCO, Saudi Arabia SFDA requirements
China NMPA, Brazil ANVISA, India CDSCO, Saudi Arabia SFDA requirements
Complete regulatory submission for a medical device from classification to approval
Complete the form below to enroll in our comprehensive Clinical Research program
Master medical device regulatory affairs skills for high-demand roles in the medical device industry, CROs, and regulatory agencies.
What you'll achieve after completing this certification
Master 21 CFR Part 820 QSR, 510(k), PMA submissions, and FDA regulatory requirements for medical devices.
Navigate the complex European Medical Device Regulation, technical documentation, and notified body interactions.
Implement ISO 14971 risk management processes throughout the medical device lifecycle.
Develop regulatory strategies for US, EU, and emerging markets including China, Brazil, and India.
Prepare complete regulatory submissions including 510(k), PMA, technical files, and design dossiers.
Understand regulatory requirements for SaMD (Software as a Medical Device) and AI/ML applications.
Establish and maintain ISO 13485 compliant quality management systems for medical devices.
Conduct clinical evaluations and prepare clinical evaluation reports (CER) according to MEDDEV 2.7/1.
Implement post-market surveillance systems, trend reporting, and vigilance requirements.
Start your pharmaceutical career journey today