LabTest can help you establish which safety and performance standards or other secondary standards are essential to sell your Medical Devices in Canada, United States, the European and Worldwide markets.
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.
LabTest is an accredited Certification Body (CB), Testing Laboratory (TL), and Inspection Body (IB) who can assist you in determining which Safety & Performance or other collateral standards are required to sell your Medical Devices to the North American, European, and 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 manufacturers with 3rd party Testing and Certification, to ensure that a product launch occurs smoothly, in a timely manner, and in the most possible cost-effective way.
Risk Assessment
The 3rd edition of IEC 60601-1, in comparison with the 2nd edition, puts emphasis on the Risk Management file and process conforming to ISO 14971, as well as essential performance.
Application of risk management to medical devices is a mandatory requirement when demonstrating compliance to the IEC 60601 series of standards. Without this documentation, compliance is not possible. LabTest can provide support and guidance on risk management and integrated quality system (ISO 13485 and/or ISO 14971) assessments.
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LabTest Certification is your ISO 17025 accredited Testing Laboratory, ISO 17065 Certification Body and ISO 17020 Inspection Body & Notified Body for all your Medical Devices Testing & Certification needs.
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