Brisbane, Australia, 14 November 2018 -- ResApp Health Limited (ASX:RAP), a leading digital
health company developing smartphone applications for the diagnosis and management of
respiratory disease, is pleased to announce that its quality management system is now
International Organization of Standardization (ISO) 13485:2016 compliant, following a successful
Stage Two Audit by BSI (The British Standards Institution). ResApp expects to receive a formal
certificate within two weeks. ISO 13485 is an essential step in obtaining European CE Mark and
Australian Therapeutic Goods Administration (TGA) approval for all of ResApp’s products.
In order to achieve ISO 13485 compliance, a company must demonstrate to an authorized third
party that it meets the ISO requirements for a comprehensive quality management system for
the design and manufacture of medical devices.
“Obtaining ISO 13485 certification is a significant accomplishment and an important milestone as
we approach commercialisation in Europe and Australia,” said Tony Keating, CEO and Managing
Director of ResApp. “In Australia there are 150 million general practitioner (GP) visits annually,
with acute upper respiratory tract infections being the most commonly managed illnesses for
patients under 45. Europe represents an even larger opportunity, with more than 6.8 billion GP
visits annually. In the UK alone, a quarter of the population visit their GP for a respiratory tract
infection at least once per year, while in the Netherlands 15% of all GP visits relate to a respiratory
tract infection. National health services across Europe are adopting new technologies such as
telehealth and AI to deliver more effective primary healthcare. Our products fit perfectly into this
growing trend. With ISO 13485 compliance now complete, we are well on our way towards
obtaining CE marking and TGA approval for our suite of smartphone applications.”
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