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.