Capturing the value of good quality in medical devices
While we harp on making diagnostics in India accessible and affordable, it is essential to do so without compromising on quality... While most of the Western world and Asia have long had regulations in place, to ensure quality standards, India has started devising its own regulatory systems for medical devices only in the recent past. With the introduction of Medical Device Rule 2017, the government is set to ensure that all medical devices, henceforth, both produced and imported, will conform to high standards. Further the recently introduced ICMED, India’s first indigenous quality assurance system for ‘Make in India’ medical devices, is aimed at enhancing patient safety, by providing product credentials to manufacturers. From the customer’s perspective, it will help in procurement of standardized products. Making regulations a part of good business practice Research shows that most organizations identify the primary role of Quality Assurance as compliance i.e. ensurin