Master Medical Device Regulatory Affairs

Explore the FDA's three-tier device classification (class 1–3) and 2024–2025 updates, including eSTAR for de novo submissions, QMSR harmonization, and AI-enabled device considerations.

Explain the EU MDR four-tier classification, rule 11 for Samd, and the 2024 transition end, highlighting software updates, enhanced transparency, and cybersecurity requirements for devices.

Master ISO 14971 risk management across the medical device lifecycle, integrating risk analysis, risk evaluation, risk controls, post-market monitoring, and cybersecurity, including threat modeling and sbom practices.

Develop strategic classification and risk-based regulatory pathways for medical devices, integrating de novo submissions, Estar readiness, AI/ML considerations, and multi-jurisdictional post-market surveillance.

Master the 510(k) pathway by demonstrating substantial equivalence to a predicate device and selecting the predicate. Learn the mandatory Estar electronic submission system since October 2023 and the NVD/IVD templates.

Understand the de novo pathway for first-of-its-kind, low to moderate risk devices without predicates, including a two-phase fda review and mandatory estar by october 2025.

Master medical device regulatory affairs explains the PMA pathway for class iii devices, detailing clinical data requirements, submission types, regulatory timelines, and innovations like Estar and change control plans.

Explore the Breakthrough Devices Program and other special pathways to accelerate regulatory review and patient access, leveraging enhanced FDA communication, prioritized review, and strategic pathway selection.

Learn to master modern FDA premarket submissions by leveraging Estar, choosing the optimal path (510(k), de novo, PMA), and assembling complete, compliant technical documentation and labeling.

Design clinical studies that meet FDA evidence requirements across 510(k), PMA, de novo, and breakthrough pathways, emphasizing GCP, IDE, risk-based design, adaptive methods, and real-world evidence.

Master future regulatory success by leveraging strategic FDA Q submissions, including pre-submission planning, issue requests, and risk determinations, while integrating international coordination to accelerate global market access.

Develop a comprehensive post-market surveillance program by integrating MDR reporting, complaint handling, and CAPA, using real world evidence and advanced analytics to ensure ongoing safety and regulatory compliance.

Explore the EU MDR (EU 2017/745), its focus on patient safety, market harmonization, transparency, and the 2024 amendments shaping AI, cybersecurity, and supply resilience.

Apply the EU MDR risk-based classification (class one to three) using 22 annex eight rules to determine regulatory oversight, CE marking, UDI rollout, and enhanced market surveillance.

Navigate the EU MDR's comprehensive clinical evidence framework, mastering the clinical evaluation process, literature review, equivalence demonstrations, and post-market clinical follow up to ensure safety and performance.

Discover the Udemy database as the digital backbone of the MDR, its six modules, and how real-time data integration strengthens market surveillance and transparency.

Develop and implement EU MDR compliance strategies by integrating regulatory requirements into core processes, performing gap and readiness assessments, and planning risk-based, phased, cybersecurity-aware implementation with continuous monitoring for 2024–2025.

Navigate EU MDR pathways and engage notified bodies for European market access; build clinical evidence and documentation, including CR, annex II/III, and post-market surveillance.

Discover how a quality management system under EU MDR builds on ISO 13485-2016 with process-based, risk-based thinking, covering design controls, manufacturing, post-market surveillance, CAPA, and training.

Explore the EU MDR's continuous, lifecycle-based post-market surveillance and vigilance framework. Design a PMP with data collection, reporting, PMCF, PSR, real world evidence, and cybersecurity vigilance.

Design and implement an ISO 13485-2016 quality management system using process-based architecture and risk-based thinking, align with FDA QMSR transition, and complete gap analysis for regulatory excellence.

Explore design controls in the medical device product development lifecycle, aligning ISO 13485 with FDA 21 CFR 820, and cover verification, validation, design transfer, agile methods, and software requirements.

Explore the ISO 14971 2019 risk management framework for the medical devices lifecycle. See how post-market surveillance, risk benefit analysis, and design control integration drive continuous improvement and regulatory excellence.

Discover how digital transformation, IoT, AI, and cloud enable real-time monitoring and predictive quality in modern QMS while advancing data integrity and regulatory harmonization.

Develop clinical evidence programs for medical devices, aligning FDA and EU MDR requirements with a lifecycle approach. Harness real world evidence, patient centered outcomes, and decentralized designs for AI/ML devices.

Examine real world evidence and registry studies as regulatory sources for post-market evaluation, and learn to design, document, and analyze EHR- and registry-derived data for FDA and MDR submissions.

Learn to build a living clinical evaluation framework under the eu mdr, from the cep and cer to a state-of-the-art evidence synthesis, equivalence assessment, and post-market updates.

Explore post-market surveillance and pmcf within the eu mdr framework, detailing vigilance, incident management, and real-world evidence to sustain device safety across the lifecycle.

Develop global market access strategies for medical devices by aligning regulatory pathways, reimbursement, evidence generation, and sustainability across markets, including HTA, real-world evidence, and companion diagnostics.

Explore global regulatory harmonization through the IMD, MRAs, and ISO standards across major markets. See how digital submissions, AI, and post-market surveillance drive faster, safer market access.

Explore four-pillar strategies to grow in emerging medical device markets, navigating regulatory maturity, infrastructure, economics, and culture, with China, India, and Brazil examples of local manufacturing incentives and risk-managed entry.

Explore how AI-driven data analytics, automated submissions, and integrated platforms accelerate global device regulation, enhance interoperability, and support patient-centered approaches, sustainability, and secure medical device governance.

Explore how artificial intelligence and machine learning transform medical devices, navigate evolving global regulations, validate performance, manage bias, and monitor real-world safety and effectiveness.

Explore the regulatory landscape for samd, software as a medical device, and digital therapeutics, focusing on risk-based classification, cybersecurity by design, and data privacy under HIPAA and GDPR.

Discover how precision medicine and additive manufacturing reshape regulation with patient matched and custom made devices, validated end-to-end processes, and companion diagnostics, alongside sustainability and circular economy considerations.