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Global Market Expansion for SaMD – Unlocking Access Across Key Markets
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Global SaMD Approval Strategy – Expanding Your Reach
With proven experience navigating requirements from authorities such as the U.S. FDA, EU under 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 across LATAM, APAC, or the Middle East, our end to end support ensures your SaMD aligns with evolving expectations for risk classification, cybersecurity, UDI systems, clinical/performance evaluation, and AI/ML specific regulations.
- Reduce time to market with region specific regulatory roadmaps
- Minimize risk through proactive strategy and gap analysis
- Ensure alignment with ISO, IMDRF, and local digital health frameworks
- Seamlessly manage submissions, technical documentation, and localization
Who We Serve
Startups & Innovators
Growing Companies Expanding Markets
Large Enterprises & Multinationals
How We Serve
Supporting new products in existing markets:
- Assist in optimizing SaMD submissions for speed and compliance.
- Ensure a streamlined approach that complies with existing Regulatory frameworks in target countries.
Supporting old products in new markets:
- 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 new products in new markets:
- 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 change in in-country representation:
- 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
- Act as the official legal manufacturer, assuming full QMS and Regulatory responsibilities.
- Maintain ongoing compliance and license upkeep across 60+ 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
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.