Healthium Medtech receive CE clearance under the EU MDR norms, the company establishes its commitment of highest safety and quality standards in the implantable medical devices sector.
New Delhi: Healthium Medtech, medical devices company focused on surgical, post-surgical and chronic care announced that it has received the new CE certification under the stringent European Union’s Medical Device Regulation (EU MDR). As a part of the regulation for CE certification, the EU MDR accreditation is mandatory for sales to European countries and several other regulated markets. The purpose of the regulation is to ensure that manufacturers produce safe products, meeting global safety standards.
Speaking about the EU MDR accreditation, Anish Bafna, Chief Executive Officer and Managing Director, Healthium Medtech, said “We are delighted to receive the CE certification under EU MDR. The certification is a testimony to our continuous commitment to operational excellence and our focus in delivering the same high quality, safe, value driven products not only to the EU but also in India and other countries. This is aligned with our vision of facilitating access to precision medtech for every patient, globally.”
Dr Ashok Moharana, Chief Medical Officer, Healthium Medtech, added “The CE certification under EU MDR reinforces our growing capabilities at Healthium towards innovation, safety, quality and clinical research for providing holistic solutions for clinicians and the patient community.”