RECENT CLIENTS
A sample of recent clients.....
2015 Hills Health in Sydney deploys nurse call technology in more hospitals and aged care facilities in Australia than any other brand. Steve provided advice on a process for selecting a manufacturer for a new Nurse Call Device. The process recommended was a ‘triple bottom line’ methodology, an objective and evidence based assessment of the supplier’s QMS, Capability (expertise, experience, resources, strategic location, lifecycle support) and cost (allowing for post manufacturing support).
2015-16 Saluda Medical in Sydney and the US develop, manufacture and distributes implantable neurostimulators for the treatment of patients with chronic back pain.
Steve was appointed Senior Vice President Quality Assurance of SALUDA MEDICAL in 2015. Steve’s task was to upgrade Saluda’s Quality Management System to be ISO 13485 compliant which included improvement to the company design control procedures and supplier management which involved on-site audits of suppliers in the USA and South America.
He successfully prepared Saluda for a BSI ISO 13485 Certification in 2016.
2017 DVT Solutions is a company that develop and manufacture medical devices for the alleviation of Deep Vein Thrombosis in the lower limbs. After a review of a the new product specification and intended market, advice was provided regarding the regulatory class of medical device and process for product approval. Advice was also provided for the content of a design dossier including the test data and qualifications required for outsourced manufacturing.
2018 Steven M Moody & Associates relocated from Coffs Harbour on the North Coast NSW, to Dalmeny on NSW South Coast. Although Steve worked primarily from offices in Sydney from Y2K to 2017, he flew each week from his home in Coffs Harbour to Sydney, or to client’s offices elsewhere in Australia and from time to time to the Americas and EU as required. For family reasons Steve and his wife moved to the south coast of NSW in 2018 but with no difference in the 1 hour flight time to Sydney where his associate consultants reside. However, the relocation resulted in a 12 month suspension of Steve’s consulting activities.
2019-20 Oventus Medical in Brisbane and the US design, develop, manufacture and distribute intraoral medical devices to reduce or alleviate snoring and obstructive sleep Apnea (OSA).
Steve was engaged to review the company QMS in 2019, assist with improvements to their documented procedures and prepare the company to pass the global Medical Device Single Audit Program (MDSAP) audit and maintain TUV ISO 13485 Certification both in Australia and the USA.
Part of suggested QMS improvements, was the acquisition and implementation of an electronic QMS (eQMS) that was initiated with the benefits of reduced paperwork for staff, speedier review and approval of documents, improved record keeping/access and overall reduced cost of document creation and control.
2020-21 SYMBYX in Sydney is a developer of groundbreaking medical devices intended for the treatment of Parkinson’s disease, dementia, Alzheimer’s and traumatic brain injury. Their devices use red, near infrared and low powered therapeutic laser technology.
Steve provided a suggested sequence of company Quality Management System (QMS) implementation that included acquisition and implementation of an electronic QMS (eQMS). He assisted with the review of eQMS platform providers, provided advice regarding the regulatory class of their new medical devices, the design documentation required and the most appropriate regulatory conformity route for product approval.
During these past projects and others over several years, Steve has worked with many quality assurance, scientific and industry experts in diverse fields of engineering. Some of these experts as well as Steve are available as part of Steven M Moody & Associates.
