Morepen Laboratories gets ISO-13485 certification for its medical devices manufacturing facility at Baddi (HP)
Apr 30, 2020
New Delhi [India] April 30 (ANI/NewsVoir): Morepen Laboratories Ltd has received the prestigious ISO-13485 certification from BSI (British Standards Institution, UK) 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.
"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 (Conformite Europeene) 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", said Sushil Suri, Chairman and Managing Director, Morepen Laboratories Ltd.
"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", claimed Suri.
Morepen has got state-of-the-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.
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 3.30 million active users of glucose monitors in the SAARC region.
Having sold over 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 2-ply/3-ply face masks, all under its umbrella brand - Dr Morepen.
The company has also recently received 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.
HCQ is a prescription based drug commonly being recommended to Corona patients under treatment for the disease. India is taking a lead in supplying HCQ to the rest of the world including USA.
India is the largest producer of HCQ and will continue to retain its leadership position in this time of crisis.
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