Morepen Labs Gets ISO-13485 Certification For Its Medical Devices Manufacturing Facility At Baddi
New Delhi: Morepen Laboratories Ltd. has received the prestigious ISO-13485 certification from BSI (British Standards Institution, U.K.) for its State-of-the-art medical devices manufacturing facility at Baddi (Himachal Pradesh). The certification has been awarded for the manufacturing, distribution and after-sales service of all point-of-care diagnostic medical devices and their accessories manufactured at the company's facility in Baddi.
The Manufacturing facility and its management systems were rigorously audited by experts and the company has been awarded the certification based on the comprehensive audit procedures undertaken by the notified body.
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 life-cycle 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, Mr 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, Mr Suri claimed.
"Morepen has got state-of-art 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", Morepen Labs added
Morepen has recently launched a wide range of essential products being required to combat the growing menace of Corona Virus 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 2-Ply/ 3-Ply Face Masks, all under its umbrella brand — Dr Morepen.
"The Company has also recently received a license to manufacture Hydroxychloroquine (HCQ) from State Drug Controller (HP) for its Baddi plant in Himachal Pradesh and is working towards commercializing the production of HCQ in both API as well as tablets form," Morepen stated