Morepen Laboratories Ltd. has received the prestigious ISO-13485 certification from BSI (British Standards Institution, U.K.) for its Stateof-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.
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.
