Medical Electrical Safety Testing Services in Compliance with EN 60601-1 Standard

Ensuring the safety of medical devices is paramount in the healthcare industry. Medical electrical safety testing, conducted in accordance with the EN 60601-1 standard and U.S. Food and Drug Administration (FDA) requirements, is crucial to guarantee the reliability and safety of these devices for their intended use.

At Sigma Scientific, we specialize in providing comprehensive medical electrical safety testing services. Our laboratory is ISO/IEC 17025 accredited and FDA ASCA accredited, demonstrating our commitment to adhering to the highest industry standards.

What is EN 60601-1?

EN 60601-1 encompasses a series of standards designed to address the safety and fundamental performance requirements for medical electrical equipment and associated systems. Compliance with these standards ensures that medical devices meet essential safety criteria, mitigating potential risks to patients and healthcare professionals.

Our Accredited Testing Services

Sigma Scientific offers a range of testing services tailored to meet the requirements of EN 60601-1 and FDA regulations. Our experienced team utilizes state-of-the-art equipment and methodologies to conduct thorough evaluations of medical devices, including:

• Electrical Safety Testing: We assess the electrical safety of medical products to identify and mitigate potential hazards associated with their use.

• Performance Testing: Our testing procedures evaluate the performance and functionality of medical devices under various operating conditions.

• Risk Management: We assist clients in identifying and managing risks associated with the design, manufacture, and use of medical devices.

• Compliance Verification: Our experts ensure that medical devices comply with relevant regulatory requirements, including EN 60601-1 and FDA guidelines.

Why Choose Sigma Scientific?

• Accredited Laboratory: Our ISO/IEC 17025 accreditation demonstrates our technical competence and commitment to quality.

• FDA ASCA Accreditation: We are recognized by the FDA as a trusted provider of medical device safety and performance testing services.

• Expertise and Experience: With years of experience in the industry, our team has the knowledge and expertise to deliver accurate and reliable testing results.

• Tailored Solutions: We work closely with clients to develop customized testing solutions that meet their specific needs and requirements.

• Timely Results: We understand the importance of timely testing and strive to deliver results promptly, enabling our clients to bring their products to market faster.

Contact Us Today

Ensure the safety and compliance of your medical devices with Sigma Scientific's accredited testing services. Contact us today to learn more about our EN 60601-1 testing services and how we can assist you in achieving regulatory compliance.