Medical Device Testing by MDS Finland

IEC 60601 Testing Services MDS Finland offers specialized testing services to ensure compliance with the IEC 60601 series, a comprehensive set of standards crucial for the safety and performance of medical electrical equipment. Our focus on adhering to these standards demonstrates our commitment to the highest levels of safety and quality in medical device development. […]

IEC 60601 Testing Services

MDS Finland offers specialized testing services to ensure compliance with the IEC 60601 series, a comprehensive set of standards crucial for the safety and performance of medical electrical equipment. Our focus on adhering to these standards demonstrates our commitment to the highest levels of safety and quality in medical device development.

Foundational Standard IEC 60601-1 Compliance

The IEC 60601-1 standard is the cornerstone of the series, setting the general requirements for basic safety and essential performance. We provide thorough testing to ensure your device meets these fundamental requirements.

Particular Standards Specific to Device Types

The IEC 60601 series branches into specific standards for various medical devices like high-frequency surgical equipment, endoscopic equipment, and infant incubators. Our testing services cover these particular standards, tailored to the specific type of medical electrical equipment you develop.

Collateral Standards for Broad-Based Requirements

We address broad-based requirements that may apply to your device through collateral standards testing. This includes Electromagnetic Compatibility (EMC), Usability Engineering Analysis, and adaptation to the Home Use Environment.

EMC Testing

Compliance with IEC 60601-1-2 for EMC is crucial to ensure that your device operates correctly in its intended electromagnetic environment. We conduct comprehensive EMC tests to prevent unacceptable electromagnetic disturbances.

Ensuring Device Usability and Safety

Our testing services extend to the collateral standards that ensure your device is userfriendly, safe, and suitable for the intended environment, whether in clinical settings or for home use.

Why Choose MDS Finland for IEC 60601 Compliance Testing?

Expertise in Medical Device Standards

Our team is highly experienced in the nuances of the IEC 60601 series, offering you precise and reliable testing services.

Customized Testing Solutions

We provide testing services tailored to the specific requirements of your medical electrical equipment, ensuring comprehensive compliance.

Commitment to Quality and Safety

Our adherence to these international standards underlines our dedication to ensuring the highest quality and safety of medical devices.

Streamlining Your Path to Compliance

At MDS Finland, our goal is to facilitate your journey towards achieving compliance with the IEC 60601 standards. By entrusting us with the testing of your medical electrical equipment, you are assured of thorough and efficient services that not only comply with regulatory standards but also uphold the highest safety and performance levels.

ISO 10993 Testing Services

MDS Finland offers comprehensive biocompatibility testing services in accordance with ISO 10993, a critical standard for evaluating the biological safety of medical devices. Our expertise in ISO 10993 testing ensures that your medical devices are thoroughly assessed for potential biological risks, supporting their safety and efficacy.

Biological Evaluation Plan (BEP)

We begin by developing a Biological Evaluation Plan (BEP), which reviews the device and its materials, identifies potential biological risks, and suggests appropriate evaluations or testing strategies.

Comprehensive Testing Phases

Our testing phase involves a combination of in vivo and in vitro biological tests, chemistry tests, and toxicological risk assessments. We also incorporate scientific literature reviews to provide a thorough assessment of the device’s biological safety.

Chemical Characterization and Analysis

Chemical characterization and analysis form a crucial part of biocompatibility testing, ensuring that any potential risks associated with materials in contact with the body are identified and assessed.

Handling Production Residuals and Batch Releases

We manage production residuals and conduct batch release testing to ensure that each product batch meets stringent safety standards.

Sterilization Validation

Our services include sterilization validation, ensuring that sterilization processes are effective and do not adversely affect the biocompatibility of the device.

Biological Evaluation Report (BER)

After completing all tests, we compile the results into a comprehensive Biological Evaluation Report (BER), documenting the findings and conclusions regarding the device’s biocompatibility.

Why Choose MDS Finland for ISO 10993 Biocompatibility Testing?

Expertise in Biocompatibility Standards

Our team is well-versed in ISO 10993 standards, providing you with accurate and reliable testing services.

Tailored Biocompatibility Solutions

We offer testing services customized to the specific biological safety requirements of your medical device.

Focus on Safety and Compliance

We are committed to ensuring that your medical devices meet all necessary biocompatibility criteria, supporting their safe use and regulatory compliance.

Ensuring Biological Safety and Regulatory Compliance

With MDS Finland, you gain a partner who is dedicated to ensuring the biological safety of your medical devices. Our ISO 10993 testing services are an integral part of your device’s compliance journey, helping you to meet regulatory requirements and ensure patient safety.