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Concept and Discovery · Global Regulatory Pathway Strategy

Lock down your multi-regime regulatory pathway, V&V matrix, and total budget before committing capital.

A single word in your Intended Use statement dictates risk classification, predicate eligibility, and clinical trial mandates across FDA, EU MDR/IVDR, MDSAP, and APAC authorities. Settle your global submission tracks, "test-once" verification matrix, and commercial sequence before Design Freeze.

Request a Global Pathway Assessment

Domain Expertise

Deep regulatory authority across every medical device domain

SaMD · AI Digital Health

IEC 62304 & IEC 82304-1 Software Lifecycle · FDA PCCP & Good Machine Learning Practice

R&D teams locking down Intended Use, essential performance, and hardware/software specifications prior to committing capital to formal V&V testing.

Active Devices · Robotics

IEC 60601-1 Ed. 3.2 & IEC 60601-1-2 Ed. 4.1 · IEC 60601-2-XX Particular Standards

Software teams structuring IMDRF SaMD risk categorization, IEC 62304 safety classes, and Predetermined Change Control Plans (PCCP) across global markets.

Implants · Biomaterials

ISO 10993-1:2018 & ISO 10993-18 E&L · ISO 11135 / 11137 Sterilization & ISO 11607

Manufacturers leveraging existing DHF and test dossiers to expand into new regulatory jurisdictions without redundant bench or clinical testing.

In Vitro Diagnostics (IVD)

EU IVDR 2017/746 & FDA IVD Guidance · CLSI EP Guidelines (EP05, EP06, EP12, EP17, EP25)

Complex devices requiring Primary Mode of Action (PMOA) determination, lead-agency assignment, and hybridized ISO 13485 / cGMP quality roadmaps.

Proprietary Data & Precedent Validation

Global Classification (FDA/EMDN/GMDN) & Predicate Precedent Cross-Validation

100% Cross-Validation of Multi-Regime Classifications & Predicate Devices

Engineered 4-Stage Workflow

4-Stage Global Strategy Pipeline from Claims Lock to Board-Ready Roadmap

Step 01 / 04Stage Gate & Output

Global Intended Use, Indications & Architecture Baseline Locked

Incomplete baseline data or misclassified regulatory pathways are the primary drivers of multi-month submission delays. Gate 01 locks the device scope, predicate/standard mapping, and full document inventory before authoring begins.

Verification Baseline

Device description, intended use, existing test reports, and QMS document index

Gate Sign-Off Output

Confirmed classification matrix and locked submission master inventory

Agentic Automation & Platform Integration

Turn Regulatory Strategy Directly into PLM Design Inputs & RIM Workflows

Automated Regulatory Requirement ↔ Design Input Traceability

Links target FDA Product Codes, EU GSPR clauses, and consensus standards directly to PLM requirements and ISO 14971 risk controls.

Explore module

@Requirements Management— Run "Automated Regulatory Requirement ↔ Design Input Traceability" across our Global Regulatory Pathway Strategy records and call out the highest-priority compliance findings first.

I'll inspect the linked quality and dossier records against target regulatory standards, then report actionable findings with verified outputs.

Thought for 4.2s · Explored Requirements Management records & 14 regulatory clauses

P1 · Verified Agent Output· Global Intended Use, Indications & Architecture Baseline Locked

Links target FDA Product Codes, EU GSPR clauses, and consensus standards directly to PLM requirements and ISO 14971 risk controls. Traceability from specification to verification

Open in Requirements Management

Structured Predicate & Standard Baseline Archiving

Converts validated predicate comparisons and standard lists directly into reusable IMDRF STED and FDA eSTAR master sections.

Explore module

@Risk Management— Run "Structured Predicate & Standard Baseline Archiving" across our Global Regulatory Pathway Strategy records and call out the highest-priority compliance findings first.

I'll inspect the linked quality and dossier records against target regulatory standards, then report actionable findings with verified outputs.

Thought for 4.3s · Explored Risk Management records & 14 regulatory clauses

P1 · Verified Agent Output· Multi-Jurisdiction Launch & Submission Tracking in RIM

Tracks pre-submissions (Q-Sub), Notified Body reviews, and country registrations across a unified global RIM timeline. ISO 14971 risk register linked to design control

Open in Risk Management

Service Specification

Service Scope & Final Deliverables

Scope

We lock in global device classification, predicate/equivalence strategy, and harmonized clinical and bench testing sequences.

  • Multi-regime qualification & classification across US FDA, EU MDR/IVDR, MDSAP, and major APAC authorities
  • Optimal pathway selection — FDA 510(k) / De Novo / PMA and EU MDR Conformity Assessment routes (Annex IX–XI)
  • Global Predicate & Equivalent Device benchmarking and Substantial Equivalence (SE) defense architecture
  • Master testing & clinical evidence sequencing leveraging IECEE CB, ILAC-MRA, and MDSAP cross-recognition
  • FDA Q-Submission (Pre-Sub) and EU Notified Body structured dialogue strategy

Deliverables

Citation-backed regulatory architecture documents engineered for R&D, RA/QA, and executive leadership.

  • Global Multi-Market Classification & Regulatory Pathway Determination Report
  • Predicate & Equivalent Device Technical Comparison Matrix
  • Harmonized Global Bench Testing & Clinical Evidence Gap Matrix
  • FDA Q-Submission / Scientific Advice Briefing Framework (where applicable)
  • Multi-Region Launch Gantt Chart, Total Cost Model, and Regulatory Risk Register
Global Regulatory Pathway Strategy — Service Scope & Final Deliverables
CategoryItem / MilestoneSpecification & Deliverable
ScopeScope 1Multi-regime qualification & classification across US FDA, EU MDR/IVDR, MDSAP, and major APAC authorities
ScopeScope 2Optimal pathway selection — FDA 510(k) / De Novo / PMA and EU MDR Conformity Assessment routes (Annex IX–XI)
ScopeScope 3Global Predicate & Equivalent Device benchmarking and Substantial Equivalence (SE) defense architecture
ScopeScope 4Master testing & clinical evidence sequencing leveraging IECEE CB, ILAC-MRA, and MDSAP cross-recognition
ScopeScope 5FDA Q-Submission (Pre-Sub) and EU Notified Body structured dialogue strategy
WorkflowStage 1: Global Product Architecture & Claims LockDefine Intended Use, Indications for Use, mechanism of action, and hardware/software architecture baselines across target markets.
WorkflowStage 2: Multi-Regime Classification & Predicate MappingCross-map FDA Product Codes, EU MDR/IVDR classification rules, and EMDN/GMDN codes while validating predicate devices.
WorkflowStage 3: Harmonized Testing, Clinical & QMS SequencingSequence ISO 13485 / FDA QMSR implementation, accredited bench testing, and clinical evaluation (CER/PER) on a unified critical path.
WorkflowStage 4: Global Master Regulatory Roadmap DeliveryDeliver an executive-ready multi-market launch sequence, itemized budget model, and regulatory risk mitigation register.
DeliverablesDeliverable 1Global Multi-Market Classification & Regulatory Pathway Determination Report
DeliverablesDeliverable 2Predicate & Equivalent Device Technical Comparison Matrix
DeliverablesDeliverable 3Harmonized Global Bench Testing & Clinical Evidence Gap Matrix
DeliverablesDeliverable 4FDA Q-Submission / Scientific Advice Briefing Framework (where applicable)
DeliverablesDeliverable 5Multi-Region Launch Gantt Chart, Total Cost Model, and Regulatory Risk Register

Frequently Asked Questions

Typically 2 to 4 weeks from intake of your device specifications and draft Intended Use statement to delivery of the complete multi-regime masterplan.

Yes—pre-Design Freeze is the highest-leverage window. Engaging before formal V&V testing allows us to lock claims, classification, and worst-case sample bracketing before capital is spent.

This universal lifecycle service architects your global baseline (IMDRF, ISO 13485, ISO 14971, IEC 60601/62304/62366, FDA, EU MDR) from a MedTech industry engineering perspective. Country-specific filings (such as our dedicated Korea MFDS tracks under /markets/korea/services) plug directly into this master architecture.

The deliverable functions as the exact engineering specification for subsequent DHF/STED Gap Analysis, Accredited V&V Testing Orchestration, Usability (IEC 62366-1), and Cybersecurity (IEC 81001-5-1) execution.

We cross-map US FDA (510(k), De Novo, PMA, QMSR), EU MDR/IVDR (GSPR), MDSAP (US, Canada, Japan, Australia, Brazil), IMDRF STED, and major APAC regulatory authorities.

Upon receiving any deficiency notice from FDA, an EU Notified Body, or an international review authority, our engineers dissect the reviewer’s finding against harmonized ISO/IEC clauses and clearance precedents. We separate items resolvable via technical justification from those requiring supplementary bench data, author the formal response dossier, and drive reviewer alignment through closure.

Yes—that is the core advantage of our universal lifecycle engineering model. By harmonizing FDA eSTAR requirements, EU MDR Annex II/III GSPR checklists, IMDRF STED templates, and multi-country IECEE CB National Deviations before testing or authoring begins, we eliminate redundant laboratory campaigns and prevent region-by-region dossier rewrites.

Our workflow is designed to protect your R&D velocity. Once your team provides baseline engineering inputs (specifications, BOM, architecture diagrams) during Stage 1 intake, Leanabl executes the heavy lifting: standard clause mapping, ISO 14971 risk traceability, regulatory authoring, and laboratory coordination. Your team only reviews and signs off at structured stage gates.

We immediately perform a multi-regime regulatory change impact assessment (covering FDA 510(k) modification guidance, EU MDR MDCG 2020-3 significant change criteria, and ISO 13485 design control) to determine whether a formal submission or internal Letter-to-File / QMS update is required. Because deliverables are modularized in our platform, only affected sections require updating.

Lock down your regulatory architecture before committing to V&V testing.

Share your device overview and target markets to receive a scoped pathway engineering proposal.

Request a Global Pathway Scope