Description

A focused course, tailored for you

Building Modern Neurotech and Brain-Computer Interface Compliance (ISO 13485 + EU MDR + FDA Combination Products + AI/SaMD + Clinical Investigation + Ethics + Multi-Country)

Build the modern neurotech and brain-computer interface compliance capability in 10 weeks. ISO 13485 + EU MDR + FDA combination products + AI/SaMD + clinical investigation + ethics + multi-country.

Neurotech and brain-computer interface (BCI) leaders face complex compliance challenges: ISO 13485 + EU MDR + FDA combination products + AI/SaMD + clinical investigation + ethics + multi-country regulatory pathway. Leaders who build the modern capability take the senior commercialisation work. Here is the 10-week build.

$199 one-time

Tailored to your situation. Access within 24 hours. 30-day money-back.

Includes a hand-built implementation playbook delivered alongside course access, generated for your specific situation.

Why this course

Neurotech and brain-computer interface (BCI) leaders (at Panaxium, Neuralink, Synchron, Blackrock Neurotech, Paradromics, Precision Neuroscience, Cognixion, Onward Medical, NeuroOne Medical Technologies, NeuroPace, LivaNova, Inbrain Neuroelectronics, Motif Neurotech, Iota Biosciences, Kernel, Mindstrong Health, Cogstate, Neurable, Neurolief, Helius Medical Technologies, NextSense, NeuraMetrix, EMOTIV, OpenBCI, AlpacaML, Saluda Medical, Magnus Medical, Magstim, MagVenture, Brainsway, Neuronetics, Neuro-Bio, Cortexyme, Cognoptix, Ax-S Technology, Tan Health, Halo Neuroscience legacy, Thync legacy, Heliospectra, Avantis Medical Systems, Imperative Care, Neurogen Biomarking) face complex compliance challenges in 2024-2026.

ISO 13485:2016 quality management system framework, EU MDR (Regulation 2017/745) class IIb/III medical device pathway with notified-body engagement, FDA combination products framework (Office of Combination Products for products combining device + drug + biologic), FDA Breakthrough Device Designation pathway, FDA Q-Sub programme, FDA 510(k) / De Novo / PMA pathway selection, FDA AI/SaMD Action Plan + PCCP guidance for AI/ML-enabled devices, EU AI Act application to AI in medical devices (high-risk Annex III for AI medical devices), clinical investigation framework (ISO 14155, EU MDCG guidance, GCP, ICH E6 R3), clinical-evaluation report framework, clinical-investigation plan framework, principal-investigator engagement framework, IRB/IEC engagement framework, ethics framework (Belmont Report principles, Helsinki Declaration alignment, neuroethics-specific considerations on mental privacy + identity + autonomy + agency, NeuroRights framework), multi-country regulatory pathway (FDA, EU EMA + member states, UK MHRA, Japan PMDA, China NMPA, Korea MFDS, Australia TGA, India CDSCO, Brazil ANVISA, Mexico COFEPRIS, Canada Health Canada, Switzerland SwissMedic, Israel Ministry of Health, Singapore HSA), cybersecurity framework (FDA Section 524B for medical device cybersecurity, EU MDR Annex I cybersecurity requirements, IEC 62443, IEC 81001-5-1, Premarket Cybersecurity Guidance), and post-market surveillance framework all need to land at the compliance-leader layer.

Leaders who build the modern capability take the senior commercialisation work. Leaders who stay on classic device-compliance-only patterns watch the senior work shift to peers.

This course teaches the 10-week build of modern neurotech and brain-computer interface compliance: ISO 13485 framework, EU MDR framework, FDA framework, AI/SaMD framework, clinical investigation framework, ethics framework, multi-country framework, cybersecurity framework, post-market surveillance framework, and the executive engagement model. Twelve modules with deliverables. Plus a hand-built implementation playbook for your specific platform.

What you walk away with

A documented ISO 13485 framework.
An EU MDR framework.
An FDA framework.
An AI/SaMD framework.
A clinical investigation framework.
An ethics framework.
A multi-country framework.
A cybersecurity framework.
A post-market surveillance framework.
An executive engagement model.
A 10-week build plan.

The 12 modules

Module 1. Neurotech and BCI compliance landscape 2026

Detailed walkthrough of the neurotech and BCI compliance landscape in 2026: peer-firm positioning at Panaxium + Neuralink + Synchron + Blackrock Neurotech + Paradromics + Precision Neuroscience + Cognixion + Onward Medical + NeuroOne Medical Technologies + NeuroPace + LivaNova + Inbrain Neuroelectronics + Motif Neurotech + Iota Biosciences + Kernel + Mindstrong Health + Cogstate + Neurable + EMOTIV + OpenBCI + Saluda Medical + Magnus Medical + Magstim + MagVenture + Brainsway + Neuronetics, regulatory landscape (FDA, EU MDR, EU AI Act, UK MHRA, Japan PMDA, China NMPA, Korea MFDS, Australia TGA, India CDSCO, Brazil ANVISA, Mexico COFEPRIS, Canada Health Canada, Switzerland SwissMedic, Israel Ministry of Health, Singapore HSA, IMDRF), neuroethics landscape (NeuroRights Foundation, IEEE Brain Initiative, neuroethics principles in Chile constitutional protection 2021, Mexico Senate neuroethics bills, Brazil neuroethics framework, Colombia draft NeuroRights bill, US BRAIN Initiative neuroethics, EU Human Brain Project ethics, UK Royal Society neuroethics, Canada SR&ED neuroethics), and the strategic-level decisions facing neurotech and BCI leaders.

Module 2. ISO 13485 framework

Build the ISO 13485:2016 framework: QMS scope-statement framework, design-controls framework, design-history-file framework, design-input framework, design-output framework, design-verification and validation framework, design-transfer framework, design-changes framework, complaint-handling framework, CAPA framework, internal-audit programme framework, management-review framework, and the integration with broader QMS.

Module 3. EU MDR framework

Build the EU MDR (Regulation 2017/745) framework: device-classification framework (class IIb/III for implantable BCI, class IIa/IIb for wearable BCI, class I for non-invasive consumer BCI), notified-body selection framework, technical-documentation framework (Annex II + Annex III), clinical-evaluation framework, clinical-investigation framework (Annex XV), conformity-assessment pathway framework (Annex IX/X/XI), CE-marking framework, UDI framework, EUDAMED framework, and the integration with broader regulatory affairs.

Module 4. FDA framework

Build the FDA framework: Combination Product framework (Office of Combination Products, primary-mode-of-action framework, RFD requests), Breakthrough Device Designation pathway, Q-Sub programme framework, 510(k) pathway framework, De Novo pathway framework, PMA pathway framework, IDE (Investigational Device Exemption) framework, expanded-access framework, and the integration with broader regulatory affairs.

Module 5. AI/SaMD framework

Build the AI/SaMD framework: FDA AI/SaMD Action Plan integration, FDA PCCP (Predetermined Change Control Plan) framework, FDA Good Machine Learning Practice principles integration, EU AI Act high-risk classification overlay for AI medical devices, IMDRF SaMD framework, model-lifecycle management framework, algorithm-locked vs adaptive-AI framework, AI model-card framework, AI training-data framework, AI explainability framework, and the integration with broader AI strategy.

Module 6. Clinical investigation framework

Build the clinical investigation framework: ISO 14155 alignment, EU MDCG clinical-investigation guidance alignment, GCP alignment, ICH E6 R3 alignment, clinical-investigation plan framework, clinical-evaluation report framework, principal-investigator engagement framework, IRB/IEC engagement framework, informed-consent framework, post-market clinical follow-up (PMCF) framework, and the integration with broader clinical.

Module 7. Ethics framework

Build the ethics framework: Belmont Report principles framework (respect for persons, beneficence, justice), Helsinki Declaration alignment, neuroethics-specific considerations (mental privacy + identity + autonomy + agency), NeuroRights framework integration (Chile constitutional 2021 + Mexico Senate bills + Brazil + Colombia + US BRAIN Initiative + EU Human Brain Project + UK Royal Society + Canada SR&ED), informed-consent for neurotech framework, vulnerable-population framework (paediatric, cognitive-impairment, locked-in syndrome), ethics-committee engagement framework, and the integration with broader ethics.

Module 8. Multi-country framework

Build the multi-country framework: US FDA framework, EU EMA + member states framework, UK MHRA framework, Japan PMDA framework, China NMPA framework, Korea MFDS framework, Australia TGA framework, India CDSCO framework, Brazil ANVISA framework, Mexico COFEPRIS framework, Canada Health Canada framework, Switzerland SwissMedic framework, Israel Ministry of Health framework, Singapore HSA framework, IMDRF harmonisation framework, and the integration with broader regulatory strategy.

Module 9. Cybersecurity framework

Build the cybersecurity framework: FDA Section 524B (Cybersecurity in Medical Devices) requirements, FDA Premarket Cybersecurity Guidance (September 2023), FDA Postmarket Cybersecurity Guidance, EU MDR Annex I cybersecurity requirements, IEC 62443 IACS cybersecurity application, IEC 81001-5-1 health software cybersecurity, EU NIS2 critical-infrastructure overlap where applicable, SBOM requirements, vulnerability-disclosure framework, and the integration with broader product security.

Module 10. Post-market surveillance framework

Build the post-market surveillance (PMS) framework: PMS plan framework, PMS report (PSUR) framework, PMCF plan and PMCF report framework, vigilance reporting framework (FDA MDR, EU MDR, FSCA, FSN), trend-reporting framework, complaint-handling integration framework, real-world-evidence framework, and the integration with broader PMS strategy.

Module 11. Executive and board engagement

Build the executive and board engagement: CEO partnership, CTO partnership, CSO partnership, CQO partnership, CRO partnership, board-of-directors engagement, scientific-advisory-board engagement, ethics-board engagement, and the integration with broader executive cadence.

Module 12. Your 10-week build plan

Week-by-week plan with weekly deliverables. Weeks 1-2: neurotech and BCI compliance landscape + ISO 13485 framework. Weeks 3-4: EU MDR framework + FDA framework. Weeks 5-6: AI/SaMD framework + clinical investigation framework. Weeks 7-8: ethics framework + multi-country framework. Weeks 9-10: cybersecurity framework + post-market surveillance framework + executive engagement. Deliverable: modern neurotech and brain-computer interface compliance.

How this addresses your situation

Specific modules that map to what you said you are dealing with.

Module 1 covers the landscape.

Module 2 produces ISO 13485.

Module 3 covers EU MDR.

Module 4 covers FDA.

Module 5 covers AI/SaMD.

Module 6 covers clinical investigation.

Module 7 covers ethics.

Module 8 covers multi-country.

Module 9 covers cybersecurity.

Module 10 covers post-market surveillance.

Module 11 covers executive engagement.

Module 12 covers the 10-week build plan.

What you get with this course

The 12-module course delivered as text plus downloadable templates.
Templates and worked examples for ISO 13485 framework, EU MDR framework, FDA framework, AI/SaMD framework, clinical investigation framework, ethics framework, multi-country framework, cybersecurity framework, post-market surveillance framework, executive and board engagement.
A hand-built implementation playbook generated for your specific platform.
Three worked examples of modern neurotech and BCI compliance capabilities at peer firms.
Scripted talking points for the CEO and ethics-board engagement.

What you will have in hand by Day 1, Week 1, Month 1

Day 1: ISO 13485 framework scaffold drafted.

Week 4: EU MDR + FDA designed.

Week 8: AI/SaMD + clinical investigation + ethics + multi-country operational.

Week 10: Capability in operation.

Before and after

Before

Your compliance practice handles classic device-compliance-only patterns. EU MDR + FDA combination products + AI/SaMD overlap strains the operation. Clinical investigation under multi-country pathway is reactive. Ethics framework is uncertain. Senior commercialisation work goes to peers shipping the modern capability.

After

A modern neurotech and brain-computer interface compliance capability is in operation. ISO 13485 framework, EU MDR framework, FDA framework, AI/SaMD framework, clinical investigation framework, ethics framework, multi-country framework, cybersecurity framework, post-market surveillance framework, executive and board engagement are all designed.

What happens if you do not address this

Leaders without the modern capability miss senior commercialisation work. EU MDR + IVDR transitions tighten; FDA AI/SaMD Action Plan + PCCP guidance active; EU AI Act high-risk obligations from August 2026; NeuroRights frameworks emerging globally.

Who it is for

For neurotech and BCI engineers, regulatory affairs leaders, quality leaders, clinical leaders, ethics leaders, and senior commercialisation leaders at neurotech and BCI firms.

Who this is NOT for. Pure non-medical AI engineers without medical device scope. Engineers at firms with no neurotech business. Pure consumer-wellness wearable firms without medical device pathway.

How it arrives

Text-based course via LMS, plus downloadable templates and worked examples and the hand-built implementation playbook.

Time investment. Roughly 18 hours of reading and 200 to 400 hours of compliance-leader effort across the 10-week build.

Why $199 is the right number

External neurotech and BCI compliance consultants (specialist firms like Emergo Neurotech, Greenlight Guru Neurotech, Maetrics Neurotech, NSF Neurotech, Oriel Stat A Matrix Neurotech, BSI Neurotech, TÜV SÜD Neurotech, DEKRA Neurotech, Big4 life-sciences neurotech practices) charge $300K-$1.5M for compliance programmes. $199 buys the focused playbook plus the implementation document for your specific platform.

FAQ

Will this replace hiring a neurotech compliance specialist?

Partially. It teaches the modern capability. You may still want specialist input for complex IDE applications.

What if my platform is primarily non-invasive (EEG/MEG/fNIRS-based)?

Modules 3 and 4 cover non-invasive-anchored patterns.

Does this cover Neuralink-style implantable BCI specifically?

Modules 3, 4, and 6 cover implantable BCI in depth.

What about consumer-wellness BCI (EEG-based wellness)?

Modules 1 and 4 cover consumer-wellness BCI patterns.

What is in the implementation playbook for me specifically?

ISO 13485 framework tailored to your specific platform; multi-country regulatory pathway matched to your target markets; a 10-week build plan.

30-day money-back guarantee. If after a week of working through the materials this is not what you needed, reply to the receipt email and a full refund is processed. No questions, no forms.

Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.