PETALING JAYA: Medical device manufacturer Geob International Sdn Bhd, a recipient of the Star Accelerator Fund, is in the process of attaining the ISO13485, a certification awarded to firms for the design and manufacture of medical devices.
The international standard specifies requirements for a quality management system to provide medical devices and related services that consistently meet customer and regulatory requirements.
Geob founder and chief executive officer Geoffrey Tan said this would qualify the Hypoband, a device worn around the wrist that can detect cold sweats and the onset of a medical emergency, as a medical device to major export markets, including the European Union.
“After the ISO certification, we will apply for a CE Mark certificate which verifies that our device meets all regulatory requirements of the EU’s Medical Devices Directive (MDD),” he said.
Tan said the certification of Hypoband as a medical device would allow customers from other countries to be exempted from customs import duty.
“Medical devices are exempted from import duty in most countries, which translates to higher profit for them and more orders as well,” he said.
Tan added that the company has been aggressively marketing the Hypoband locally and overseas via its website and to pharmacies, hospitals, local and international distributors in the Middle East, Singapore and Malaysia.
Tan got the idea to create the product when his father, a diabetic on insulin treatment, experienced frequent hypoglycaemic attacks.
“I needed a cold sweat detector that can make phone calls automatically so I can be warned by my father who would be wearing the Hypoband (in the form of a wrist band), hence a remote connectivity device is built in,” he said.
The Hypoband is paired to smartphone via bluetooth, which would make a phone call or SMS when the Hypoband detects cold sweat during hypoglycaemic attacks.
The smartphone is driven by a mobile application that makes this decision based on prefix threshold settings.
Tan, a mechanical engineer by profession, said many diabetics suffer hypoglycaemic attacks and many of them have complications and even fatal coma.
