The safety and effectiveness of medical devices are of utmost importance to public health. IEC (International Electrotechnical Commission) standards play a crucial role in the certification and regulation of these devices, ensuring they meet the highest quality and safety standards. The IEC works closely with governments and regulators to develop standards that protect both patients and healthcare professionals.
IEC standards for medical devices cover a wide range of aspects, including electrical safety, electromagnetic compatibility, equipment performance and software requirements. These standards are essential to ensure that medical devices operate safely and effectively in a variety of clinical environments. Additionally, the IEC provides ongoing support for updating these standards to reflect technological advances and changing clinical needs.
IEC also collaborates with other international organizations to harmonize global standards, facilitating international trade and mutual acceptance of medical devices between different countries. This harmonization effort helps reduce technical barriers and promotes innovation in the healthcare sector.
At PCN, we are committed to applying these standards in our certification processes. We act proactively in the national and international regulatory environment to provide our clients and partners with a cutting-edge view of the regulatory and conformity assessment environment.
We provide conformity assessment services that ensure medical devices meet stringent IEC standards, promoting patient safety and healthcare professional confidence.
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