EnScientific Testings and Certification can help you establish which safety and performance standards or other secondary standards are essential to sell your Medical Devices globally.
Medical Devices
Rapid evolution and innovation in Healthcare technology is what allows for more and more lives to be saved or enhanced every day. But before new Medical devices can be brought to market and used in a medical working environment, they must first meet the requirements as set by the local regulations.
This means that it is necessary to determine if a device can perform effectively without causing harm and/or electromagnetic disturbances in its specific operating environment. Products must be tested to the applicable standards of the market (country) they are intended for, to ensure they meet the safety and performance requirements as outlined in the main standard and in the collateral standards (if applicable). Once they do, they get approved.
Our Medical Device
EnScientific Testings and Certification is a Testing Laboratory, and Inspection Body who can assist you in determining which Safety & Performance or other collateral standards are required to sell your Medical Devices to the global markets.
Our safety experts acknowledge the challenges associated with Safety and Electromagnetic Compatibility (EMC) testing of medical products for global export and therefore, provides Testing and Certification, to ensure that a product launch occurs smoothly, in a timely manner, and in the most possible cost-effective way.
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Testing & Certification
Testing & Certification
Product testing and certification to national and international standards in the areas of Electrical, PPE, Hazardous Locations, EMC, Gas, Plumbing, Marine, Solar, Energy Efficiency, Building Materials, Environmental Testing
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Field Evaluations
Field Evaluations are onsite product approvals designed for limited quantities or specialized equipment where certification is not the fastest or most cost effective option
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Management Systems Services
EnScientific Certification offers Training, Assessment, and Certification in compliance with ISO 9000 series of standards to help you make your business stand out from the competition!
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Training Program
Our extensive in-house knowledge and high levels of expertise allow us to provide the support you need to achieve complete confidence in the subject area you are seeking training for. Training available online and in-person.
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