Sigma Software Achieves ISO 13485 Certification

A Testament of our Quality Management System for Medical Devices

19 Feb, 2025

3 min read

Sigma Software has officially received ISO 13485 certification, marking a significant milestone in our journey to deliver the highest quality, reliability, and safety standards in our software development services in the healthcare field.

Designing, developing & supporting healthcare products since 2002, Sigma Software is constantly strengthening its offering in this industry, meeting new technology challenges, ensuring compliance with healthcare regulations like HIPAA, FDA, HHS, and DEA, and proving our commitment to quality receiving corresponding certifications. As yet another milestone in this process, in January 2025, Sigma Software achieved ISO 13485:2016 certification.

What is ISO 13485?

ISO 13485 is an internationally recognized standard for quality management systems for the medical devices industry. It ensures that organizations adhere to stringent quality controls and regulatory requirements in the design, development, production, and maintenance of medical devices. By achieving this certification, Sigma Software demonstrates its ability to consistently meet customers’ and regulatory requirements, ensuring the highest level of safety and efficacy.

Working with world-renowned clients like AstraZeneca, Siemens Healtheneers, CompuGroup Medical, and others, we strive to maintain the highest quality level they expect from their providers and demonstrate the safety and reliability of our software solutions.

Achieving ISO 13485 certification is no small feat. A company-wide effort is required to evaluate our quality management processes and ensure they comply with the standard’s requirements.

This included:

Implementing robust risk management process.
Adopting best practices in software design and development for medical software.
Conducting extensive internal audits and training sessions to ensure compliance across all teams.
Partnering with external experts to validate and refine our processes.

Since Sigma Software is ISO 9001 and ISO/IEC 27001 certified, we are familiar with the certification procedures and have dedicated specialists responsible for standards and compliance in our company.

We adhere to high industry standards in quality and information security management, delivering trusted services to our clients worldwide. With ISO 13485 certification, we have once again proven that Sigma Software meets the highest international medical device design and manufacturing standards.

“Achieving ISO 13485 certification is an important step for Sigma Software and our partners in the healthcare sector. This certification underscores our commitment to providing safe, high-quality, and innovative software solutions for medical devices. It also opens new doors for collaboration with global healthcare leaders,” says Andrii Pastushok, Director of Business Development for Healthcare at Sigma Software.

Ready to Partner with Us?

We would love to hear from you if you’re looking for a reliable ISO 13485-certified software development partner to bring your medical device solutions to life. Let’s work together to create technologies that improve lives and set new standards in the healthcare industry.

Sigma Software

Software Engineering Company

Sigma Software provides IT services to enterprises, software product houses, and startups. Working since 2002, we have build deep domain knowledge in AdTech, automotive, aviation, gaming industry, telecom, e-learning, FinTech, PropTech.We constantly work to enrich our expertise with machine learning, cybersecurity, AR/VR, IoT, and other technologies. Here we share insights into tech news, software engineering tips, business methods, and company life.

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