SaMD Regulatory Compliance,
Registration & Global Market Access 

Bring Your SaMD to Market Faster with a clear 
Global Regulatory Pathway

  • End-to-end regulatory strategy
  • Submission support
  • QMS implementation
  • AI/ML compliance planning
  • Lifecycle support for Software as a Medical Device

Trusted Partner for SaMD & Digital Health Companies

  • Regulatory strategy for US, EU, UK, and priority global markets
  • FDA 510(k), De Novo, and PMA support for SaMD
  • EU MDR / IVDR classification, CE-marking, and technical documentation support
  • ISO 13485, IEC 62304, ISO/TR 80002, ISO 14971, and software lifecycle-aligned QMS implementation
  • AI/ML change governance, cybersecurity, and post-market compliance support

Why SaMD Companies Need a Different Regulatory Approach

Software as a Medical Device requires more than a one-time submission. It requires continuous compliance checks as software updates. Today’s regulatory expectations extend across classification, clinical/performance evidence, cybersecurity, software lifecycle controls, algorithm updates, and post-market change management.

Freyr helps SaMD innovators build a practical, submission-ready pathway that aligns product intent, evidence strategy, quality systems, and regional market requirements from day one.

Talk to a SaMD Regulatory Expert

Our SaMD Regulatory Services

  • Intended use and claims review
  • Product qualification and risk classification
  • Standards mapping and gap assessment
  • Region-specific pathway selection
  • Submission and market-entry planning
  • 510(k), De Novo, and PMA pathway support
  • Pre-submission planning and documentation strategy
  • Technical file and evidence-readiness review
  • Cybersecurity documentation support
  • Post-market change and lifecycle support
  • MDR Rule 11 assessment and classification support
  • EU MDR / IVDR pathway strategy
  • Technical documentation and GSPR alignment
  • Clinical / performance evaluation support
  • Notified Body readiness and post-market obligations
  • AI-enabled SaMD regulatory pathway planning
  • Change-control and model update strategy
  • Validation, transparency, and traceability support
  • AI governance readiness for evolving US and EU expectations
  • Lifecycle oversight for continuous improvement 
  • ISO 13485-aligned QMS design
  • IEC 62304 software lifecycle process integration
  • Risk management and traceability frameworks
  • SOPs, CAPA, design controls, and audit readiness
  • Scalable QMS for startups, growth companies, and global teams 
  • Multi-country registration planning
  • Regional pathway alignment across key markets
  • Labeling, UDI, and local compliance support
  • In-country representation coordination where required
  • Ongoing post-market and maintenance support
  • Software Development Service
  • Software Verification and Validation
  • Software Requirement Sheet Specification
  • Code Review and Bug Fixes 
  • SaMD Regulatory Strategy & Product Assessment
  • FDA SaMD Registration Support
  • EU SaMD Registration & CE Marking
  • AI/ML SaMD Compliance Support​
  • SaMD QMS Implementation & Remediation​
  • Global Market Expansion for SaMD​
  • SaMD Development and Software Testing Services

Our SaMD Regulatory Services

SaMD Regulatory Strategy & Product Assessment

  • Intended use and claims review
  • Product qualification and risk classification
  • Standards mapping and gap assessment
  • Region-specific pathway selection
  • Submission and market-entry planning

FDA SaMD Registration Support

  • 510(k), De Novo, and PMA pathway support
  • Pre-submission planning and documentation strategy
  • Technical file and evidence-readiness review
  • Cybersecurity documentation support
  • Post-market change and lifecycle support

EU SaMD Registration & CE Marking

  • MDR Rule 11 assessment and classification support
  • EU MDR / IVDR pathway strategy
  • Technical documentation and GSPR alignment
  • Clinical / performance evaluation support
  • Notified Body readiness and post-market obligations

AI/ML SaMD Compliance Support​

  • AI-enabled SaMD regulatory pathway planning
  • Change-control and model update strategy
  • Validation, transparency, and traceability support
  • AI governance readiness for evolving US and EU expectations
  • Lifecycle oversight for continuous improvement 

SaMD QMS Implementation & Remediation​

  • ISO 13485-aligned QMS design
  • IEC 62304 software lifecycle process integration
  • Risk management and traceability frameworks
  • SOPs, CAPA, design controls, and audit readiness
  • Scalable QMS for startups, growth companies, and global teams 

Global Market Expansion for SaMD​

  • Multi-country registration planning
  • Regional pathway alignment across key markets
  • Labeling, UDI, and local compliance support
  • In-country representation coordination where required
  • Ongoing post-market and maintenance support

SaMD Development and Software Testing Services

  • Software Development Service
  • Software Verification and Validation
  • Software Requirement Sheet Specification
  • Code Review and Bug Fixes 

Trusted by SaMD Innovators Navigating Complex Global Pathways

Success Stories

 

Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.

Regulatory Affairs
Arie Henkin

VP - Quality and Regulatory, Australia -based, Leading SaMD Company

Medical Devices

Registration and LR Support

Global

 

I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.

Regulatory Affairs
Darren Mansell

Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company

Medical Devices

Swiss Rep Services

Japan and Switzerland

 

Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.

Regulatory Affairs
Robert Menadue

Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company

Medical Devices

Registration and AR Services

Malaysia and Indonesia

 

We are impressed with Freyr’s support in providing us with quick and well-detailed solutions to our queries. Freyr’s constant support to adapt to ever-changing Regulatory conditions while providing support with any additional queries we had in a timely manner has truly impressed us.

Regulatory Affairs
Sergey Burlov

Quality Manager, Russia-based, Innovative SaMD Company

Medical Devices

Registration and LR Services

Brazil

 

FREYR has accompanied us with the registration of several products on the UK market. They have always been quick to reply, attentive to our needs, a great source of Regulatory information and support. The price is reasonable compared with other similar service providers. We particularly appreciate the personalized quarterly and annual status reports that Freyr provides. When we call on FREYR, we know they will do their best to satisfy our needs, and that customer satisfaction is a priority.

Regulatory Affairs
Pascale LE BAUD

Regulatory Affairs Associate - RA Department, France-based, Leading Synthetic Implants Manufacturing Company

Medical Devices

UKRP Support

UK

What You Gain

How We Support Your SaMD Journey

  • Assess product intent, claims, and classification
  • Develop software and testing protocols
  • Define the right US, EU, or global regulatory strategy
  • Prepare technical documentation, evidence, and quality-system inputs
  • Submit with market-specific regulatory support
  • Sustain compliance through post-market, cybersecurity, and change management

Who This Is For

  • SaMD startups preparing for first-market entry
  • Medtech companies, Pharmaceutical companies, Cosmetic companies, Software Development Companies and Hospitals with a Digital Health Portfolio
  • Digital health companies expanding from one region to another
  • AI/ML software teams needing a compliant update strategy
  • MedTech companies remediating QMS or strengthening submission readiness
  • Global teams building a multi-market expansion roadmap

Frequently Asked Questions