Portal Instruments, a clinical stage medical device start-up company announced today that it has received ISO (International Organization for Standardization) 13485:2012 Certification by the National Standards Authority of Ireland (NSAI) certifying body.
ISO 13485:2012, Quality Management Standard for Medical Devices is the international standard requirements for a comprehensive quality management system for the design and manufacture of medical devices. This certificate of registration from an independent organization ensures that Portal’s Quality Management System has been assessed and deemed to comply with the requirements of the ISO 13485:2012 standard within the scope of the following operations – namely the design, manufacture and distribution of hand-held needle-free injection devices for drug administration. A key attribute of ISO 13485 certification is that it is a regulatory precursor for global market entry.
“We are delighted to receive ISO 13485 certification from NSAI,” said Patrick Anquetil, CEO of Portal Instruments. “This certification provides current and future customers with confidence and trust in Portal’s Quality Management Systems and strengthens Portal’s commitment to client quality and end-user service. It is a first step in positioning the company for expansion in the medical device marketplace.”
The Portal drug delivery technology is needle-free, fast and computer-controlled. It automatically adjusts the injection velocity up to one thousand times in the half-second it takes to completely deliver a 1 ml dose. The result is the precise administration of high viscosity biologic drugs through the skin, via an extremely collimated jet, the size of a strand of hair. HIPPA-compliant, automatic collection and transfer of injection and health data sets a new standard of engagement between the care team and the patient. With a clear view of patient behavior, protocols can be better managed, research is better informed and compliance is improved.
“ISO 13485 certification shows Portal Instruments’ on-going commitment to ensuring that the medical devices designed and built comply with state-of-the-art standards, and are manufactured under closely monitored processes that ensure the consistent quality of their products,” said Chris Morrell, Vice President of NSAI Inc.
