Support for IEC 60601 Compliance, Including General Safety and EMC Compliances

Welcome to Safetek’s IEC 60601 Compliance Support! We assist medical device manufacturers worldwide in meeting regulatory requirements for safety and EMC.

Expertise in IEC 60601 Standard

Our regulatory consultants possess extensive knowledge and expertise in the IEC 60601 standard, which sets the requirements for the safety and performance of medical electrical equipment. We assist you in understanding and implementing the relevant provisions of the standard to achieve compliance.

General Safety Compliance

Ensuring the safety of medical devices is of paramount importance. Our team guides you through the general safety requirements specified in the IEC 60601 standard. We help you identify potential hazards, mitigate risks, and implement appropriate safety measures, such as electrical insulation, mechanical safety, and protection against electrical shock.

Electromagnetic Compatibility (EMC) Compliance

Electromagnetic compatibility is critical to the proper functioning and safety of medical devices. We provide comprehensive support in achieving EMC compliance as per the requirements outlined in the IEC 60601 standard. Our experts assist in evaluating electromagnetic emissions and immunity, ensuring that your devices operate safely in the presence of electromagnetic fields.

Compliance Review and Gap Analysis

We conduct thorough compliance reviews and gap analyses of your medical devices to identify any deviations from the IEC 60601 standard. Our team assesses your existing documentation, design controls, and risk management practices to ensure they align with the specific requirements. We provide detailed reports highlighting areas for improvement and recommend corrective actions.

Testing and Verification

To ensure the compliance of your medical devices, we offer comprehensive testing and verification services. We have access to state-of-the-art testing facilities and laboratories equipped with the necessary equipment to assess general safety and EMC compliance. Our experts oversee the testing process and provide guidance on interpreting the test results.

Regulatory Submission Support

Preparing and submitting regulatory documentation is a crucial step in demonstrating compliance with the IEC 60601 standard. Our organization assists in the preparation of technical files, including safety and EMC reports, to support your regulatory submissions. We ensure that your documentation meets the specific requirements of regulatory authorities in Brazil, Japan, USA, Australia, Canada, and other target markets.

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