Expert guidance for every stage of your SaMD

Build and certify your SaMD with expert guidance and streamlined documentation to reduce compliance stress and focus on safe, high-quality software.

Software as a Medical Device dashboard with structured regulatory documentation
Straight-on SaMD compliance dashboard showing completed workflow steps with green checkmarks and approved badges

Reduce compliance stress with SaMD-specific guidance

  • Navigate FDA and EU software regulations with confidence

  • Implement risk management and documentation efficiently

  • Avoid delays with clear, actionable regulatory advice

Accelerate your software approvals

  • Streamline submissions and regulatory reviews

  • Streamline submissions and regulatory reviews

  • Reduce back-and-forth with regulators and notified bodies

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Practical regulatory solutions for every device

Build software that meets regulatory standards

We guide your team through SaMD-specific regulatory requirements, helping your software comply with FDA, EU MDR/IVDR, and ISO 13485 while improving efficiency, accuracy, and quality.

Protect users and stay audit-ready

We help you identify, assess, and mitigate risks in your software, including cybersecurity, algorithm safety, and clinical performance. This ensures your SaMD is secure, reliable, and ready for audits or regulatory review.

Maintain compliance after launch

Our team supports ongoing monitoring, post-market surveillance, and software updates, helping your SaMD remain compliant and safe while adapting to evolving regulations and market needs.

“Working with Monir and Fatemeh was a pleasure. Their expertise, professionalism, and timely, organized responses ensured the success of our Technical File assessment. Monir’s MDR knowledge is exceptional, and Fatemeh’s thorough, conscientious work made the process seamless.”

Logo of Kinepict, a medical and health services company
Zoltan Dr. Balogh

VP Regulatory Affairs

Support for Every Stage of SaMD Development

Icons representing smart software design, regulatory strategy and submissions, quality management system (QMS / QMSR), and ongoing safety and compliance for medical devices

Smart Software Design

Structure software design, implement coding standards, and integrate risk management practices. Ensure your SaMD meets regulatory expectations and performs reliably in real-world use.

Prepare Technical Documentation in compliance with local legislation and standards like IEC 62304. Ensure submissions are clear, complete, and aligned with regulatory requirements.

Implement software-focused QMS and FDA QMSR practices. Ensure testing, validation, and documentation are tracked, controlled, and always ready for regulatory review.

Maintain safety and compliance across the full lifecycle. Include cybersecurity monitoring, bug tracking, updates, and post-market surveillance. Stay aligned with evolving software standards.

 

Identify the right Notified Body for your device and manage the full application process. Include dossier submission and meeting coordination. Support a smooth and successful certification.

 

Manage EUDAMED registration start to finish, including actor registration (SRN) and device submissions. Ensure accurate, compliant data while reducing administrative workload.

 

Develop complete clinical documentation, including CEP, CER, and PMCF. Ensure clinical evidence is robust, compliant, and aligned with Notified Body expectations.

 

Ready to bring your software to market confidently?