Special Regulatory Support for Software as a Medical Device (SaMD) and AI Medical Devices

At easyQ Solutions, we are proud to be the best consulting firm specializingin
Software as a Medical Device (SaMD) and AI/ML-powered
medical technologies.

We provide dedicated Regulatory consultants with extensive knowledge of
AI/ML-based technologies and Software as a Medical Device (SaMD).

our clients

Trusted by Medtech Leaders Globally

The Regulatory and QMS requirements of AI/ML and SaMD applications in healthcare are changing and evolving with rapid growth. At easyQ Solutions, we go beyond simply staying up to date by actively tracking global regulatory changes to help you stay ahead and avoid any disruptions in compliance.

Our team has hands-on experience with key standards and guidance documents including IEC 62304, FDA guidance, and MDCG documents related to software development.

But more significantly, we take the time to learn about your company and product so that we can modify these specifications to meet your needs.

We are aware of the importance of clinical validation, AI development methodologies, and cybersecurity for AI/ML-based SaMD. To make sure your compliance is ingrained from the beginning, we offer end-to-end support, helping you every step of the way.

Let easyQ Solutions be your partner in navigating the complex world of AI/ML and SaMD regulations.

Our Services Include

Our consultants at easyQ Solutions offer special expertise to help you navigate the complexities of global approval processes ensuring you stay ahead in a regulatory environment that is becoming more complicated.

Our experts are aware of the particular difficulties SaMD and AI-based devices encounter in regulatory settings.

We offer end-to-end support across regions, including FDA (USA), EU MDR (Europe), and CDSCO (India) and other global approvals from pre-market strategy to post-market surveillance.

Working closely with you, our experts make sure your device is compliant with both technical requirements and evolving regulatory guidelines, including algorithm transparency, clinical evaluation, and cybersecurity considerations.

We support medical device manufacturers and companies with a comprehensive range of services including:

Proficiency in compiling complicated documents including:

510(k)
PMA
De Novo submissions
Technical Files
GSPRs
Plant Master Files
Device Master Files

Specialized support for IEC 60601-1 (general safety) and IEC 60601-1-2 (EMC requirements).
Guidance in preparing for and navigating testing procedures.
Risk mitigation and compliance assurance through in-depth regulatory knowledge.

Compliance with international Standards like IEC 62304 and other requirements.
Detailed review and alignment of documentation with international guidance.
Ongoing support to keep up with evolving global cybersecurity expectations.

Development of human factor validation protocols.
Expert assistance in planning and conducting usability testing.
Support to ensure product design meets efficiency and user-safety standards.

QMS Implementation
Internal Audit
Gap Asessment
Risk Management
Sipport in External Audit

Why Our Experts for SaMd & AI Medical Devices Global Regulatory Approvals?

Comprehensive Understanding of IEC 62304 and Global Standards

Extensive knowledge of IEC 62304 and other international standards governing software development for medical devices and SaMD.

Practical Application of Software Regulatory Requirements

Skilled in integrating the requirements of ISO 13485, 21 CFR Part 820, and IEC 62304 directly into the software development lifecycle, ensuring both compliance and efficiency.

Expertise in Medical Device Cybersecurity

Strong understanding of cybersecurity principles, including threat assessment, risk mitigation, and secure design aligned with global regulatory expectations (FDA, MDCG, etc.).

Deep Insight into AI/ML Development for Healthcare

Thorough knowledge of the AI/ML development process, including data handling, model validation, and compliance with evolving regulatory frameworks for AI-based medical software.

Agile and Compliance-Driven Work Methodology

We follow a smart, agile methology that combines regulatory rigor with speed helping you accelerate development while maintaining full compliance.

Expertise in Emerging Technologies

At easyQ Solutions, expertise in SaMD and AI medical device compliance is held by our regulatory specialists.

Global frameworks like FDA, CDSCO, and EU MDR are navigated by us to ensure that international safety, performance, and documentation standards are met by your medical device, allowing you to confidently enter global markets.

get started

Proven Success Across Global Markets

We are aware of how SaMD and AI medical devices are dynamic.

We have a strong track record of assisting successful submissions, from FDA 510(k) and PMA to CDSCO device registration and EU MDR Technical Files.

We have helped SaMd/Ai medical device companies of all sizes, from start-ups to major corporations, acquire regulatory success across global markets.

get started

Up to Date with Evolving Guidelines

SaMD and AI regulations are continuously evolving. We stay ahead of these changes to ensure your device remains compliant with the latest standards.

get started

End-to-End Support

From classification and pre-market strategy to post-market surveillance and monitoring, we offer comprehensive services throughout the regulatory journey.

get started