The ISO-13485 standard is an international standard which specifies requirements for Quality Management Systems (QMS) that are to be used by an organization involved in one or more stages of the lifecycle of a medical device. This certification is recognized by most regulators across the globe including those in the United Kingdom and the European Union. Compliance with this standard ensures the consistent production, delivery and after sales service of medical devices that are safe for their intended purpose.
Speaking on the development, Sushil Suri, chairman and managing director, Morepen Laboratories Ltd., said, “This ISO-13485 certification opens new vistas for Morepen to export its diagnostic devices to various countries across the globe and also to seek CE (Conformité Européene) Certification for the European Union. Having complied with all the important technical and regulatory guidelines for the Quality Management Systems as per ISO-13485, the company is confident of securing CE certification for its products as a next step.”
With the grant of ISO-13485 Certification, Morepen Labs’ diagnostic devices are expected to become the preferred choice for customers seeking high quality products manufactured as per best industry practices, Suri claimed.
Morepen has facilities in Baddi (HP) for manufacturing of medical devices including blood glucose meters, blood glucose testing strips, blood pressure monitors, thermometers, pulse oximeters, stethoscopes etc. It is one of the largest manufacturers for point-of-care diagnostic devices in India by unit volumes, especially for blood glucose monitors with over 3.3 million active users of glucose monitors in the SAARC region. Having sold more than 425 million blood glucose testing strips, the company enjoys a leadership in the segment and is well positioned to take a lead in home diagnostic products being marketed and promoted under its brand Dr. Morepen Home Health.
Morepen has recently launched a wide range of essential products being required to combat the growing menace of coronavirus disease and to prevent further spread of this disease in the country. These include non-contact infrared thermometers, alcohol-based hand sanitizers, hand wash, hand rubs and two-ply/ three-ply face masks, all under its umbrella brand — Dr. Morepen.