Master’s in Regulation and Regulatory Affairs (MDR/IVDR, FDA 510(k)/De Novo, ISO 13485)
Online master's programme of 1,900 hours in regulation and regulatory affairs (MDR/IVDR, FDA 510(k)/De Novo, ISO 13485). 12 modules covering the fundamentals, Regulation (EU) 2017/745 (MDR) and ISO 13485, advanced modelling and simulation with OpenSim, design, materials, systems integration, risk management, validation, operation and project management, with an assigned technical tutor.
Master’s in Regulation and Regulatory Affairs (MDR/IVDR, FDA 510(k)/De Novo, ISO 13485) — studying from the United States
Health technology and biomechanics form a significant sector in the United States, anchored by medical device hubs in Minnesota, Massachusetts, California and New Jersey. Companies develop implants, diagnostic equipment, rehabilitation devices and wearable sensors under strict regulatory oversight. Engineers apply biomechanical modeling, human factors and operational safety analysis to improve device performance and worker well-being. Careers often involve close collaboration with clinicians and regulatory affairs teams.
Fees for the United States: US$9,970 (US Dollars), with instalments and employer sponsorship available.
Relevant bodies in the United States
Typical roles
Questions from the United States
Which professional bodies in the United States relate to this area, and does a SEIUM qualification make me a licensed engineer?
In the US, the Professional Engineer (PE) license is issued by state licensing boards and generally requires an ABET-accredited engineering degree, supervised experience, and passing the FE and PE exams. Biomedical and safety work also connects to bodies such as ASME and IEEE EMBS. A SEIUM qualification is a private qualification, not a state degree, and does not itself grant PE licensure. Recognition is decided by employers or the relevant licensing body.
Where do people with this training typically work in the United States?
Careers in this area commonly appear in medical device companies, wearable technology firms, hospitals and research institutions, and occupational safety departments in industrial employers. Hiring decisions depend on each employer's requirements and how they value private, non-accredited training, so you should check specific job postings and speak with target employers before enrolling.
Can I study this programme while working full time in the US?
The programmes are 100% online and taught in English, so you can study from home and no student visa is needed. Master's programmes total 1,900 hours, postgraduate diplomas 800 hours, and specialist courses 300 hours, so you should plan your weekly hours realistically. Fees are payable in instalments, and some employers offer sponsorship, which you can ask your employer about directly.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Master the technical fundamentals of regulation and regulatory affairs (MDR/IVDR, FDA 510(k)/De Novo, ISO 13485) and its regulatory vocabulary.
Apply Regulation (EU) 2017/745 (MDR), ISO 13485 and IEC 62304 to real design and validation decisions.
Build and correlate calculation models with OpenSim and AnyBody Modeling System.
Plan and run test campaigns in a motion analysis laboratory and an implant test bench.
Analyse operating data and turn it into engineering decisions.
Prepare the technical and compliance dossier required by the client or the regulator.
Lead a project in regulation and regulatory affairs (MDR/IVDR, FDA 510(k)/De Novo, ISO 13485) technically from start to finish.
Who it's for
- Biomedical engineers looking to specialise in regulation and regulatory affairs.
- Biomechanics specialists seeking to broaden their technical profile.
- Healthcare regulatory affairs managers.
- Medical software engineers.
- Clinical trials technicians.
- Orthotics and prosthetics designers.
- Engineering or science graduates aiming to move into the medical device sector.
What you'll work with
- Regulation (EU) 2017/745 (MDR) (EU Medical Device Regulation)
- ISO 13485 (quality management systems for medical devices)
- IEC 62304 (medical device software life-cycle processes)
- ISO 14971 (risk management for medical devices)
- IEC 60601 (safety of medical electrical equipment)
- ISO 10993 (biological evaluation and biocompatibility)
- ISO 14155 (clinical investigation of medical devices)
- Regulation (EU) 2016/679 (General Data Protection Regulation)
- UNE-EN ISO 22442 (medical devices utilising animal tissues)
- OpenSim
- AnyBody Modeling System
- Mimics
- 3-matic
- ANSYS Mechanical
12 modules
1.1Fundamental concepts and magnitudes of Regulation and Regulatory Affairs (MDR/IVDR, FDA 510(k)/De Novo, ISO 13485)1.2Technological landscape and state of the art1.3Technical terminology and reference documentation1.4Physical and engineering principles applied to the case1.5Functional architecture: from requirements to components1.6Interfaces and dependencies with adjacent systems1.7Typical use cases in the sector1.8Common errors and how to detect them in time1.9Data sources and quality criteria1.10Exercise: guided initial diagnosis
2.1Applicable regulatory framework: overview2.2Regulatory hierarchy and conflicts between standards2.3Mandatory requirements versus good practice2.4Acceptance criteria and required evidence2.5Technical documentation and traceability2.6Change management and configuration control2.7Audits, inspections and non-conformities2.8Responsibilities and allocation of scope2.9Interpretation of critical clauses2.10Exercise: regulatory compliance checklist
3.1Setting up the model: hypotheses and simplifications3.2Selection of tools and working environment3.3Preparation of input data3.4Workflow and good modelling practice3.5Discretisation and case preparation3.6Boundary conditions and load cases3.7Convergence control and numerical verification3.8Sensitivity analysis and parametric study3.9Automation and reuse of models3.10Exercise: building a base model
4.1Reduced-order and detailed models4.2Coupling between physical domains4.3Parameter calibration with real data4.4Uncertainty propagation4.5Multi-objective optimisation4.6Digital twins and in-service models4.7Computational cost and calculation strategies4.8Cross-validation of results4.9Model documentation and versioning4.10Exercise: complete simulation campaign
5.1Design requirements and starting criteria5.2Solution alternatives and comparative analysis5.3Sizing and safety margins5.4Selection of materials, equipment or components5.5Integration with the rest of the system5.6Cost, schedule and manufacturing constraints5.7Reliability, maintainability and service life5.8Sustainability and efficiency in design5.9Design review and risk management5.10Exercise: documented design proposal
6.1Material families and selection criteria6.2Critical components and their failure modes6.3Manufacturing processes and their limits6.4Tolerances, fits and dimensional control6.5Treatments, coatings and protection6.6Emerging technologies applicable to Regulation and Regulatory Affairs (MDR/IVDR, FDA 510(k)/De Novo, ISO 13485)6.7Obsolescence and continuity of supply6.8Environmental footprint and circular economy6.9Qualification of components and suppliers6.10Exercise: comparative technical data sheet
7.1System architecture and functional breakdown7.2Interface definition and control7.3Protocols and data exchange7.4Progressive integration and interface testing7.5Electromagnetic and environmental compatibility7.6Configuration management of the whole system7.7Resolving conflicts between subsystems7.8Commissioning of the integrated system7.9Traceability from requirements to verification7.10Exercise: interface matrix
8.1Hazard identification and preliminary analysis8.2Failure modes and effects analysis8.3Fault trees and quantitative analysis8.4Allocation of reliability targets8.5Barriers, redundancy and fault tolerance8.6Human factors and operating errors8.7Safety evidence and argumentation8.8Risk management throughout the life cycle8.9Indicators and in-service monitoring8.10Exercise: risk analysis of a case
9.1Verification and validation strategy9.2Test plan: scope and coverage9.3Instrumentation and data acquisition9.4Laboratory testing versus field testing9.5Correlation between model and measurement9.6Treatment of uncertainty and tolerances9.7Failure analysis and corrective actions9.8Commissioning and acceptance criteria9.9Documentation of the validation file9.10Exercise: validation report
10.1Commissioning and handover to operation10.2Preventive and predictive maintenance plans10.3Condition monitoring and diagnostics10.4Spare parts, logistics and availability10.5Obsolescence management and upgrades10.6Availability and performance indicators10.7Life-cycle cost10.8Life extension and repowering10.9Decommissioning and end of life10.10Exercise: maintenance plan
11.1Scope, schedule and cost of the technical project11.2Estimation and budget control11.3Procurement and supplier relations11.4Technical teams and communication11.5Technical and economic feasibility analysis11.6Environmental and social criteria11.7Sustainability regulations and reporting11.8Change management and stakeholders11.9Project close-out and lessons learned11.10Exercise: business case
12.1Choice of topic and scope of the work12.2State of the art and literature review12.3Problem statement and objectives12.4Applied research methodology12.5Technical development supervised by the thesis director12.6Analysis of results and discussion12.7Conclusions and future lines of work12.8Writing the dissertation12.9Preparing the defence12.10Master's Thesis: defence before a panel and assessment
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. No fixed timetables: you progress at your own pace within each intake, so you can combine the programme with your job.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is OpenSim, AnyBody Modeling System, Mimics, 3-matic and ANSYS Mechanical, in free, academic or evaluation versions. Testing is studied through real procedures from a motion analysis laboratory, an implant test bench and a biocompatibility chamber. Assessment is continuous for each module, plus the Master's Thesis.
Standards covered: Regulation (EU) 2017/745 (MDR), ISO 13485, IEC 62304, ISO 14971, IEC 60601, ISO 10993, ISO 14155, Regulation (EU) 2016/679, UNE-EN ISO 22442.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree is required.
- Internet connection and a computer able to run the programme software.
- English sufficient to read technical standards.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme totals 1,900 hours over 12–14 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.
You work with OpenSim, AnyBody Modeling System, Mimics, 3-matic and ANSYS Mechanical, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.
A SEIUM Institute diploma, awarded on passing the continuous assessment and the Master's Thesis. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the higher programme. Ask about the recognition policy when you enrol.
Prior technical training or professional experience in the sector (no university degree required), a computer able to run the programme software and English sufficient to read technical standards.
Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.
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