,Achieve Operational Excellence and Regulatory Confidence with a Compliant QMS
In the fast-paced medical device and health tech ecosystem, quality is a strategic differentiator, not just a compliance requirement. A robust, standards-driven Quality Management System (QMS) ensures safety, performance, and Regulatory readiness across the product lifecycle.
At Freyr, we deliver customized QMS solutions aligned with global standards like ISO 13485, IEC 62304, ISO 14971, IEC 82304-1, FDA 21 CFR Part 820, and ISO/IEC 42001, among others. For AI-driven medical devices and SaMD, we also align with ISO/IEC 27001 to ensure data security and compliance. Whether you're launching a SaMD, expanding into global markets, or enhancing existing systems, our experts ensure your QMS is efficient, scalable, and audit ready.
From design to deployment, Freyr helps you integrate quality into every phase, minimizing risk, accelerating compliance, and enabling global growth.
Our Global Market Expansion Services for SaMD
Startups & Innovators
Building a medical device or SaMD from the ground up? We help you develop a lean, compliant QMS framework that meets ISO 13485 and other key standards—without overcomplicating your workflow. Our startup-centric approach ensures readiness for audits and approvals from day one.
Growing Companies Expanding Markets
As your portfolio or geography expands, we assist with scaling and localizing your QMS to meet the requirements of target markets like the U.S., EU, Canada, and Asia-Pacific. Our modular, risk-based strategies ensure your QMS grows with your business.
Large Enterprises & Multinationals
We support global companies in harmonizing and enhancing existing QMS systems to align with evolving Regulatory standards, including FDA’s QMSR and MDR/IVDR requirements. Our expertise lies in simplifying complex documentation, integrating cross-functional processes, and ensuring global audit readiness.
Applicable Global Standards We Implement
| Standard | Scope |
|---|---|
| ISO 13485 | Core global standard for QMS in medical devices |
| IEC 62304 | Software lifecycle management for medical software and SaMD |
| ISO 14971 | Risk management processes across product lifecycle |
| IEC 82304-1 | Health software product safety and usability |
| FDA 21 CFR Part 820 | U.S. Quality System Regulation (QSR) |
| FDA QMSR (upcoming) | Proposed alignment with ISO 13485 |
| AAMI TIR57 / TIR97 | Cybersecurity guidance for medical software & SaMD |
| ISO/IEC 42001 | AI Management System Standard – governance, transparency & accountability |
| ISO/IEC 27001 | Information security for AI-driven and cloud-based medical systems |
Our QMS Implementation Services
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QMS Framework Development & Customization
We design and implement complete QMS structures that are fully tailored to your business model, product class, and market focus.![]()
ISO 13485 Certification Readiness
Our team ensures your QMS aligns with ISO 13485 requirements for both certification and continuous improvement.![]()
SDLC Compliance – IEC 62304 Integration
For software-driven products, we embed Software Development Lifecycle (SDLC) practices in line with IEC 62304 to ensure development traceability and Regulatory acceptance.![]()
Risk Management – ISO 14971
We support the creation and maintenance of risk management files, incorporating use-related risks and design mitigations.![]()
AI Governance – ISO/IEC 42001 Alignment
We help build structured AI governance frameworks that prioritize transparency, risk management, and ethical AI use, aligning with the world’s first AI Management System standard.![]()
Information Security – ISO/IEC 27001 Compliance
For AI-driven, cloud-based, and mobile-integrated devices, we implement security protocols to protect sensitive health data and align with global privacy regulations like GDPR and HIPAA.![]()
Cybersecurity Compliance
Integration of cybersecurity frameworks in line with FDA, IMDRF, MDCG, and AAMI guidelines for modern connected devices.
Explore Cybersecurity Services →![]()
Human Factors Engineering (HFE)
HFE processes are integrated into QMS documentation and product development workflows for usability compliance.
Explore HFE Services →![]()
Training, SOP Development & Internal Audits
We create and implement documentation, SOPs, and training modules to help maintain a culture of quality and ensure audit readiness.![]()
Global Regulatory Alignment
We align QMS with regional requirements across the U.S., EU, UK, Canada, Australia, Japan, and other markets.
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
- Pre-built, ISO 13485-compliant QMS available immediately
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?
The cost of implementing a comprehensive Quality Management System can range from $300,000 to $500,000, depending on the organization’s size, product complexity, and the Regulatory markets being targeted. This includes framework development, SOP creation, training, and audit readiness.
More than 70% of startups fail quality audits due to incomplete documentation, lack of traceability in design and development processes, and poorly defined risk management procedures. Establishing a lean yet compliant QMS early can mitigate these risks.
Delays in achieving Regulatory compliance due to QMS misalignment can cost companies up to $1 million or more in lost time-to-market, missed revenue opportunities, and resource drain.
QMS misalignment is a leading cause of 510(k) application rejections. Submissions are often denied or delayed when the underlying quality processes do not meet FDA expectations, particularly around design controls, risk files, and software lifecycle documentation
The Freyr Advantage
- 2100+ Regulatory experts across 8 global delivery hubs
- Proven expertise in QMS implementation for over 20 countries
- Support for ISO 13485, MDSAP, FDA QSR, MDR, IVDR, and more
- Seamless integration of SaMD, Cybersecurity, and HFE requirements
- Trusted by 1550+ global customers—from early-stage startups to Fortune 500 companies
Case study
End-to-end QMS Implementation for SaMD
A US-based Life Sciences Consulting Firm partnered with Freyr for end-to-end QMS implementation for their SaMD. Freyr developed a risk management plan, trained staff on SOPs, and ensured ISO 13485-compliant execution.
