The regulations process surrounding medical devices involves a strict adherence to regulatory compliance throughout a device’s life-cycle. Medical devices, healthcare cloud platforms and services are expected to be compliant with the applicable regulations and laws. Data privacy and data security related to sensitive patient information is of utmost importance. Even a single compliance issue can have a significant effect on business. For every end- to-end medical device development project, we apply an arduously thought-through Regulatory strategy and homologation plans to get the right submissions for timely certification from Regulatory bodies.
Our ‘Design For Safety’ and ‘Design For Security’ approach always bear the “Patient first” criteria to make the products very safe, secure and reliable.
Our dedicated team of regulatory experts ensure that each product we offer or the project we undertake, is meticulously assessed, tested, and documented to meet the stringent demands of various international regulatory authorities. From initial concept to final delivery, we employ a holistic approach to regulatory activities.
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