Tridib Haldar

Background

About Tridib Haldar

Medical devices save lives! The sooner you can get your medical device out to the market the sooner it can help people. But before you can do that you need to achieve medical device compliance. Patients expect medical devices to be safe. My Job is to prove medical device compliance to safety. It guarantees patients that the device they are using is in fact safe. I am a young man from India passionate about technology and health care. I specialize in regulatory affairs for Medical devices. I have working experience with medical device regulations in India (Medical Device Rules 2017); Europe CE Marking as per EU Medical Device Regulation (2017/745); US FDA -510k & Emergency Use Authorizations; Australia TGA - ARTG Listing; UK MHRA - DORS Registrations & UKCA Marking. Familiar with regulations in Middle East and LATAM countries. Have Good Knowledge on ISO 13485 Quality System Standards. Excellent project management abilities including facilitation organization and time management. Talented at providing regulatory leadership for New Product Development and Change Management Activities. There is a real person behind this profile too!. An adventure buff and an adrenaline junkie. In my free time you might find me running (marathons) travelling gaming hiking and photography (I don’t like to advertise this fact but I’d do this job for free).