SaMD Regulatory Expertise for Every Stage, Every Size, Every Need

From QMS setup to Market approvals, we guide you through every step of the Regulatory process.

Navigating SaMD Regulations: Strategy, Compliance & Growth

Whether you are a start-up taking your first steps, a company expanding into new markets, or a large enterprise seeking specialized Regulatory expertise, navigating the complex and ever-evolving Regulatory landscape of SaMDs can be daunting. Freyr’s Regulatory services are designed to provide tailored support to meet your organization's unique needs, ensuring compliance, market access, and successful commercialization of your product.

Tailored Regulatory Solutions for Every Stage of Your SaMD Journey

Navigating Regulatory requirements for Software as a Medical Device (SaMD) can be complex, especially in the early stages of development. Freyr bridges the gap between Regulatory compliance and technology, ensuring a seamless path to market. We help design a Regulatory-compliant foundation that supports immediate approvals and long-term scalability across markets. With our expertise, you can confidently align innovation with Regulatory standards while focusing on product development.

Let Freyr simplify compliance so that you can accelerate innovation.

Your Path to Market Success

Regulatory Strategy & Market Entry Acceleration
- Regulatory Roadmap
- Gap analysis & Risk assessment for compliance readiness
- Product Registration
- Authorised Representative
SaMD-Specific Compliance & QMS Implementation
Seamless Continuous Compliance
- Post-Market Surveillance
- Lifecycle Management

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Already have an approved device and looking to expand into new markets? Each country has its own Regulatory requirements, and our team specializes in helping you navigate these differences. At Freyr, our experts are dedicated to helping your product break into new markets while ensuring alignment with your global expansion goals. With proven expertise in navigating Regulatory compliance and registration services across 120+ countries, we empower your business to thrive anywhere in the world.

No matter where your strategy leads, Freyr is your trusted partner to keep you compliant and confident every step of the way.

Your Blueprint for Regional to Global Expansion

Global Expansion Strategy
- Market Access prioritization Roadmap
- Target-country Regulatory Intelligence (RI)
- Product Registration
- Authorized Representative
- Gap analysis and Risk assessment
Regulatory and Quality Compliance
Continuous Compliance
- MOH Interaction
- Post-market Surveillance
- Lifecycle Management

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Staying compliant in a dynamic Regulatory environment requires adaptability. Whether aligning with new standards, addressing specific compliance gaps, or managing post-market surveillance, having the right expertise at the right time is key to uninterrupted operations. We can provide expertise and services in silos when you need it, as you need it, to keep your projects on track and compliant.

Enabling Seamless & Continuous Compliance

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Do You Know?

Companies invest over $500,000 in Regulatory processes

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%.

About 90% of SaMD startups face delays due to incomplete Regulatory documentation

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.

Post-market Surveillance (PMS) reports under IVDR/MDR take up to 4-12 months to update

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.

Complex Documentation & Regulatory Expertise Gaps are Major Hurdles for SaMD Companies

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 struggle to find the right Regulatory expertise

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.