A complex regulatory landscape
Medical-device and IVD requirements vary by market, product classification, intended use, and risk. A clear strategy is essential before resources are committed.
Regulatory & CRO services
From regulatory strategy to clinical execution in Japan.
America Angel Medical helps global medical-device and IVD teams turn complex market requirements into a coordinated, practical development program.
Discuss your program
Why work with a CRO
Complex requirements need coordinated expertise.
A specialist CRO helps close resource and knowledge gaps while keeping regulatory, quality, clinical, and operational workstreams aligned.
Requirements across the lifecycle
Regulatory work extends beyond an application to quality systems, clinical evidence, risk management, change control, and post-market responsibilities.
Specialist execution
A CRO adds focused expertise and project capacity, coordinating documentation, partners, studies, and authority interactions around one development plan.
Japan regulatory support
A clearer path into the Japanese market.
Engage one focused service or combine capabilities into a coordinated regulatory workstream.
PMDA registration
Pathway planning, dossier coordination, authority consultation support, and submission management.
Device classification
Early classification and regulatory-route assessment based on intended use, claims, and risk.
Clinical trial import
Import planning for investigational devices, IVDs, comparators, and clinical research supplies.
Importer of Record
Structured in-country import coordination aligned with product, labeling, and program requirements.
OEM support
Specification, manufacturer, quality-documentation, and market-readiness coordination.
Regulatory consulting
Focused guidance for critical decisions throughout the Japanese product lifecycle.
CRO capabilities
Quality, clinical, and operational support around one program.
Our modular support model is designed for medical devices and in vitro diagnostics preparing for Japan and other regulated markets.
Quality systems
Certification & QMS readiness
Gap assessment, documentation preparation, and implementation support for quality and regulatory frameworks.
- ISO 9001
- ISO 13485
- MDSAP
- FDA QMSR / 21 CFR Part 820
- EU MDR & IVDR
Audit support
Factory audit readiness
Practical preparation for manufacturing-site reviews, including evidence organization and response coordination.
- Document gap review
- Mock audit preparation
- On-site coordination
- Finding & CAPA support
IVD clinical services
Study design through final report
Coordinated validation and clinical-performance programs designed around the product and target-market evidence needs.
- Validation & clinical study planning
- Ethics / IRB submission support
- Study execution coordination
- Statistics & clinical reporting
Study operations
Biospecimen & trial logistics
Operational support connecting qualified sources, documentation, transport, and study teams.
- Biospecimen sourcing coordination
- Clinical material import
- Labeling & handling support
- Chain-of-custody documentation
Engagement process
A transparent path from consultation to delivery.
Initial consultation
We clarify the product, target market, current status, and core development challenge.
Gap assessment
Specialists review the available evidence, quality documentation, and regulatory pathway.
Scope & proposal
We define deliverables, responsibilities, timelines, partners, and a tailored quotation.
Contract & execution
The project team coordinates documentation, studies, imports, and stakeholder activities.
Submission & closeout
We support authority submission, responses, final reporting, and agreed follow-up actions.
Final scope, responsibilities, and timelines are confirmed after the initial assessment.
Start a conversation
Contact our team Build the right regulatory and clinical plan for Japan.
Share your product, current development stage, and target timeline. We will help identify the most practical next step.