Global SaMD Approval Strategy – Expanding Your Reach
Expanding Software as a Medical Device (SaMD) solution across global markets requires more than just innovation, it demands a deep understanding of region-specific Regulatory frameworks and strategic foresight. At Freyr, we specialize in simplifying the complex Regulatory pathways that vary significantly across countries and continents.
With proven expertise in navigating regulations from key authorities such as the U.S. FDA, European Union under EU MDR, Australia’s TGA, Health Canada, Japan’s PMDA, China’s NMPA, Brazil’s ANVISA, and South Korea’s MFDS, we deliver market-specific Regulatory intelligence and execution strategies that are both agile and scalable.
Whether you're entering mature markets like the United States and Europe or unlocking opportunities in emerging markets across LATAM, APAC, or the Middle East, our end-to-end support ensures your SaMD complies with evolving requirements such as risk classification, cybersecurity standards, UDI systems, clinical evaluation, and AI/ML-specific regulations.
At Freyr, we don’t just guide you through compliance, we partner with you to:
- Reduce time-to-market with region-specific Regulatory roadmaps
- Minimize risk through proactive Regulatory strategy and gap analysis
- Ensure alignment with ISO, IMDRF, and local digital health frameworks
- Seamlessly manage submissions, technical documentation, and localization
From early-stage Regulatory planning to post-market support, Freyr empowers your SaMD’s success across borders. Let us be your trusted global Regulatory partner in driving digital health innovation worldwide.
How We Serve
Supporting new products in existing markets:
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- Assist in optimizing SaMD submissions for speed and compliance.
- Ensure a streamlined approach that complies with existing Regulatory frameworks in target countries.
Supporting new products in new markets:
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- Develop Regulatory strategies from the ground up for early-stage companies.
- Provide end-to-end support—from understanding local regulations to compiling technical files—for global expansion.
Supporting old products in new markets:
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- Help growing companies and multinationals navigate new regional requirements for previously approved products.
- Adapt existing product documentation to meet new country-specific Regulatory expectations.
Supporting change in in-country representation:
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- Enable seamless entry and operations in new countries by facilitating updates or changes in local authorized representatives.
- Ensure ongoing compliance with local Regulatory authorities when shifting representation or expanding geographically.
Supporting as contract legal manufacturer
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- Act as the official legal manufacturer, assuming full QMS and Regulatory responsibilities under ISO 13485:2016.
- Maintain ongoing compliance and license upkeep across 50+ markets, enabling faster go-to-market without the need for your own QMS or ISO certification.
- Ensure continuous alignment with evolving global Regulatory requirements, allowing you to focus entirely on innovation and customer delivery.
Applicable Global Standards We Implement
| Standard | Scope |
|---|---|
| FDA 21 CFR Part 820 | U.S. Quality System Regulation (QSR) for SaMD |
| EU MDR 2017/745 | Medical Device Regulation for SaMD in the EU |
| TGA (Australia) | Therapeutic Goods Administration regulations for SaMD in Australia |
| KFDA (South Korea) | Korean FDA requirements for SaMD |
| ISO 13485 | Global standard for Quality Management Systems (QMS) for medical devices |
| IEC 62304 | Software lifecycle management standard for SaMD |
| ISO 14971 | Risk management process for SaMD development and lifecycle |
Our Global Market Expansion Services for SaMD
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Regulatory Strategy Consultation for Global Expansion
We work with you to create a tailored Regulatory strategy that aligns with your target markets, whether it's the US, EU, Australia, South Korea, or other regions. Our experts ensure that your submission process is optimized for speed and compliance.![]()
SaMD Registration in Key Markets
From FDA 510(k) to EU MDR and TGA approvals, we guide you through the necessary steps to get your SaMD registered in key markets. Our services ensure all technical documentation, clinical evaluations, and risk management practices are in place for successful market entry.![]()
Australia TGA Registration
For SaMD entering the Australian market, we manage the entire TGA registration process, ensuring compliance with the Therapeutic Goods Administration’s Regulatory requirements.
Explore Australia TGA Services![]()
South Korea SaMD Registration
Navigating South Korea’s MFDS regulations requires deep expertise. We provide strategic guidance to ensure your SaMD complies with South Korea’s Regulatory requirements, from pre-market approval to post-market surveillance.
Explore South Korea SaMD Services![]()
Risk Management – ISO 14971
We ensure your SaMD complies with global risk management standards, including ISO 14971, providing you with the necessary documentation and processes for international market entry.
Read more.![]()
Clinical Evaluation & Post-Market Surveillance
Our team helps you prepare comprehensive Clinical Evaluation Reports (CER) and ensures your product’s post-market surveillance (PMS) meets the ongoing requirements of all global markets.
Read more .
Challenges vs. Your Benefits with Freyr’s SaMD Solutions
Key Challenges
01
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.
Your Benefits
- Quick, audit-ready compliance—even when regulations evolve
- Quick, audit-ready compliance—even when regulations evolve
02
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
03
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
Do You Know?
Manufacturers now face a significantly higher Regulatory cost burden. Costs associated with clinical or performance evaluation, Post-Market Surveillance (PMS), and certification have escalated sharply. Partnering with Freyr helps you reduce the cost upto 50%.
Regulatory documentation gaps significantly delay SaMD startups, as unclear expectations for clinical data and real-world evidence lead to lengthy reviews and multiple deficiency rounds. Without well-defined conformity assessment requirements, startups face increased timelines and costs, impacting their market entry. Streamlining documentation processes can help mitigate these delays and support faster Regulatory approvals.
Under IVDR/MDR, Post-Market Surveillance (PMS) requirements have significantly increased, requiring extensive data collection, evaluation, and reporting to enhance patient safety. While 70% of manufacturers update their PMS reports within four (4) months, around 30% take up to 12 months or longer, with some exceeding 20 months. With Freyr, we provide end-to-end PMS management, ensuring continuous compliance even after your product launch.
SaMD companies face significant hurdles due to complex documentation requirements and gaps in Regulatory expertise. The evolving Regulatory landscape demands extensive technical documentation, rigorous clinical validation, and adherence to varying global compliance standards, making it challenging for companies to navigate approval processes efficiently. Partnering with Freyr for Regulatory compliance ensures streamlined documentation, expert guidance, and faster market approvals, enabling SaMD companies to focus on innovation and growth.
Over 90% of SMEs face significant challenges in finding the right Regulatory expertise, which hampers their ability to navigate evolving compliance requirements, secure certifications, and accelerate market entry. The complexity of Regulatory frameworks, coupled with resource constraints, often leads to delays and increased operational costs. Partnering with Freyr for Regulatory compliance ensures access to a team of seasoned experts, streamlining the approval process and enabling businesses to focus on innovation and growth.
The Freyr Advantage
- 2100+ Regulatory experts across 8 global delivery hubs
- Proven expertise in SaMD registration across US, EU, Australia, South Korea, and more
- Customized Regulatory strategies for global expansion
- Expertise in technical file compilation, clinical evaluation, and risk management
- Trusted by 1550+ global customers—from startups to multinational companies
Case Study
From Korea to ASEAN, MENA, and LATAM: Overcoming Regulatory Hurdles for a SaMD Launch
Discover how Freyr tackled key challenges to deliver multi-country Regulatory Intelligence, device registration, and Authorized Representative services for the client’s SaMDs and the tangible benefits it brought them. Dive into this successful case.
