Eliminate the complexities in medical device compliance with LTTS QARA services
The new Medical Device Regulation (MDR) has brought about a significant change in the Clinical Evaluation Reports (CER). The discussions around In Vitro Diagnostics Regulation (IVDR) and the growing adoption of Software as a Medical Device (SaMD) have further added to the complexity. As a result, the global medical devices ecosystem is experiencing new uncertainties. While the changes are important for ensuring patient safety, it will take some time before the ecosystem adjusts to this new regime. Nonetheless, companies that stay ahead of the curve and invest in MDR and SaMD capabilities will be better positioned to succeed in the long run.
At L&T Technology Services (LTTS), we take pride in our team of highly skilled engineers and technologists who have decades worth of partnership experience with global medical OEMs. By leveraging our expertise, we are well-equipped to assist manufacturers in implementing the new MDR and SaMD standards, as well as revitalized CERs. As part of our global initiative, we are helping redefine support delivery parameters for leading pharma and medtech companies worldwide. Our deep understanding of the latest industry standards allows us to offer our clients tailored solutions that meet their unique needs while ensuring compliance with regulations. At LTTS, we are committed to staying at the forefront of technological advancements, enabling us to provide cutting-edge services to our clients.
Learn how LTTS QARA can help you eliminate the complexities of medical device compliance.