Overview
At Freyr, we specialize in navigating the complex landscape of Software as a Medical Device (SaMD) regulation to accelerate your path to global market access. Our team provides end-to-end compliance solutions for innovative medical software, ensuring adherence to key standards such as IEC 62304, ISO 13485, and MDR/IVDR requirements.
We facilitate seamless approval processes across major markets, including the United States and European Union. Our experts assist with FDA 510(k) submissions, ensuring your SaMD meets all necessary criteria for safety, efficacy, and performance. In the EU, we support CE marking applications, guiding you through MDR and IVDR compliance to achieve timely market entry.
With proven experience in Regulatory strategy, technical documentation, gap analysis, and risk management, Freyr is your trusted partner for fast, compliant, and successful product launches. Whether you're seeking FDA clearance, CE marking, or global Regulatory harmonization, we deliver tailored solutions to help your medical software reach patients worldwide.
Regulatory Strategy Consultation Services
Our end-to-end Regulatory consultation solutions are aligned with regional requirements and SaMD risk profiles. Our offerings include:
- Initial assessment of your SaMD product, its functionality, intended use, and market goals
- Review of technical documentation and identification of compliance gaps
- Risk classification based on country-specific frameworks
Explore Risk Classification - Mapping of applicable standards (ISO 13485, IEC 62304, IEC 82304-1, etc.)
- Identification of key Regulatory pathways – including 510(k), CE, MDL, Shonin/Ninsho, and others
Each deliverable is tailored to the product type, its intended geography, and your commercialization timeline.
Regulatory Pathways and In-country Representation
Freyr’s Regulatory experts are equipped to guide you through region-specific market access pathways:
- U.S. FDA: SaMD classification, 510(k), de novo, PMA pathways
- Europe (EU MDR): Qualification as MDSW, CE conformity via Class I-III
- Japan: PMDA compliance via Shonin/Ninsho for Class II/III software
- Global: Explore other countries here
Where required, we also serve as your in-country Regulatory representative, ensuring local presence and seamless communication with Health Authorities.
Regulatory Intelligence & Roadmap Development
We provide real-time insights and predictive Regulatory intelligence for your SaMD’s target markets.
![Regulatory Intelligence (RI)]()
Periodic updates on evolving regional requirements (FDA guidance, MDCG notes, PMDA revisions, etc.)![A single partner for everything]()
Horizon scanning for Regulatory trends affecting AI/ML-based SaMDs![submission accuracy- ensuring]()
Competitor pathway mapping and benchmarking![On-ground experts with deep knowledge]()
Detailed Regulatory roadmap aligned with your launch plan
Periodic updates on evolving regional requirements (FDA guidance, MDCG notes, PMDA revisions, etc.)
Horizon scanning for Regulatory trends affecting AI/ML-based SaMDs
Competitor pathway mapping and benchmarking
Detailed Regulatory roadmap aligned with your launch planFreyr’s Regulatory roadmap outlines step-by-step actions across pre-submission, documentation,
submission, and post-approval stages-enabling faster decision-making and budget forecasting.
Global Strategy and Market Expansion
Beyond country-specific compliance, our strategic consultation services support cross-market SaMD expansion.
- Comparative Regulatory mapping across 10+ regions
- Product adaptability and submission reuse strategy
- Cross-functional input from clinical, cybersecurity, and QMS experts
- Tailored approaches for simultaneous multi-market submissions
As digital health goes global, Regulatory scalability becomes a growth driver.
Challenges vs. Your Benefits with Freyr’s SaMD Solutions
| Key Challenges | Your Benefits |
|---|---|
| 1. Complex & Evolving Regulations Navigating US FDA 21 CFR Part 820, EU MDR, ISO 13485, ISO 14971, IEC 62304, GDPR, and more can delay development without a certified QMS. | ✅ Quick, audit-ready compliance—even when regulations evolve ✅ Pre-built, ISO 13485-compliant QMS available immediately |
| 2. High Costs & Fragmented Efforts Hiring experts and coordinating with multiple stakeholders (Notified Bodies, Authorities, Consultants) is costly and inefficient. | ✅ Full QARA team for a flat monthly rate ✅ Over 50% cost savings compared to hiring in-house ✅ Less than 1 FTE cost for complete coverage |
| 3. Long & Risk-Prone Timelines QMS setup (12 months), CE marking (up to 24 months), FDA registration (3–24 months) prolong go-to-market and invite costly errors. | ✅ Save up to 6 months on QMS & ISO certification ✅ Avoid costly rework with expert-led documentation ✅ Save at least €50K on ISO and eQMS costs ✅ 100% success rate in global registrations |
