Medical Devices & IVD — Global Market Access
Global Regulatory Coverage
Medical Devices & IVD — Global Market Access
Regulatory strategy and compliance programs for medical devices and IVDs across FDA, EU MDR/IVDR, Health Canada, TGA, and international markets.
Medical device and IVD regulation has undergone significant transformation in recent years — with the EU MDR and IVDR creating substantially more demanding requirements for CE marking, and FDA's QMSR replacing 21 CFR Part 820 with an ISO 13485-aligned framework. Navigating these changes while maintaining market access and managing development timelines requires regulatory expertise that is current, practical, and globally aware. Tomorrow's Crop provides medical device and IVD regulatory consulting that keeps your products in market and your regulatory programs aligned with current requirements.
What We Do
A detailed breakdown of our capabilities in this practice area.
FDA Medical Device Regulatory Affairs
FDA regulatory affairs for medical devices — including 510(k), De Novo, PMA, and HDE strategy and preparation, pre-submission meetings, and post-market compliance.
EU MDR & IVDR Compliance
EU MDR (2017/745) and IVDR (2017/746) compliance programs — including clinical evaluation, technical documentation, notified body selection, and CE marking strategy.
QMSR Implementation
Implementation of FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820 as revised effective February 2026) — aligning your quality system with the ISO 13485-based QMSR requirements.
ISO 13485 Certification
ISO 13485 quality management system implementation and certification support — including gap assessment, system development, and notified body audit preparation.
Clinical Evaluation & PMCF
Clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) plans for EU MDR compliance — demonstrating clinical safety and performance for CE-marked devices.
Technical Documentation
Technical documentation development for EU MDR and IVDR — including device description, design and manufacturing information, performance data, and risk management documentation.
International Device Registration
Device registration strategy and support for Health Canada, TGA, PMDA, and other international markets — coordinating multi-market registration programs efficiently.
Post-Market Surveillance
Post-market surveillance programs for medical devices — including MDR reporting, FSCA management, and periodic safety update reports (PSURs) for EU MDR compliance.
How We Work
Device Classification & Pathway Assessment
We assess device classification and regulatory pathway for each target market — identifying the applicable requirements and optimal submission strategy.
Global Strategy Development
We develop a global regulatory strategy — harmonizing development activities across markets and defining the optimal sequence for market entry.
Technical Documentation Development
We develop or support development of technical documentation — including clinical evaluation, risk management, and design documentation.
Submission Preparation
We prepare regulatory submissions — 510(k)s, PMAs, technical files, and registration dossiers — for each target market.
Post-Market Compliance
We support post-market compliance — including MDR reporting, FSCA management, and periodic review of post-market surveillance data.
Outcomes You Can Expect
Why Tomorrow's Crop
Medical device regulation is one of the most technically demanding areas of regulatory affairs — requiring expertise in device classification, clinical evaluation, quality systems, and the specific requirements of each major regulatory market. Our medical device regulatory consultants have navigated FDA, EU MDR, and international device registration programs across device categories.
Deepen Your Knowledge
Insights, ready-to-use documents, and training programs related to this practice area.
Insights
- Building a QMS for a Regulated Startup
- Understanding FDA Inspection Priorities in 2026
- GMP Fundamentals: What Every Food Manufacturer Needs to Know
Document Resources
- 510(k) Submission Preparation ToolkitTC-REG-SPEC-004
- EU MDR Technical Documentation GuideTC-DEV-ADV-001
- ISO 13485 / QMSR Gap AssessmentTC-DEV-FUND-001
- Post-Market Surveillance ProgramTC-DEV-FUND-002
Ready to move forward?
Schedule a discovery call and let's define the right engagement for your organization.