CLIENTS
MedSource Technologies in Minneapolis USA acquired Texcel in Massachusetts in 1999 along with seven other best in class component manufacturers for medical device companies. Steve was tasked with corporatising the groups Quality Managements Systems (QMS) and in collaboration with the quality managers of the other subsidiaries, he created a corporate quality policy, manual and top level standard operating procedures and arranged TUV-SUD ISO 13485 certification for all subsidiary companies.
However, when MedSource insisted Steve relocate to their head office in Minneapolis, he decided to resign and move back to Australia in year 2000 and re-activate Steven M Moody & Associates to provide engineering, quality assurance and regulatory support for more Australia companies.
A sample of clients served since year 2000
2000-2005 Ventracor Limited in Sydney designed, manufactured implantable artificial heart pumps. The Company's primary product was the VentrAssist Left Ventricular Assist Device (LVAD) intended for congestive heart failure patients. From Y2K Steve provided advice on the LVAD design to facilitate the laser welding of the many parts of the pump. Then in 2003 engaged to perform a QMS audit and subsequently to upgrade the company QMS to enable ISO13485 certification and provide guidance on facility and product design for manufacturing processes. From 2004 to 2005 he was contracted to develop and implement new design control procedures and design history files for the LVAD system.
2005-6 Ritract Limited (RTL) in Sydney developed the Australian retractable safety syringe. Steve developed a compliance plan to create a QMS for the company to meet ISO13485 and FDA Quality System Regulation (QSR) 21 CFR Part 820. The plan that was adopted recommended tasks, timelines and cost estimates for implementation and certification.
Steve produced a Quality Manual and Standard Operating Procedures for RiTract, facilitated implementation of an electronic QMS (eQMS) and assisted with the completion of product design and development including design verification, validation and transfer to manufacturing in China.
In 2006 Steve prepared RiTract for a TUV-SUD ISO Certification Audit and subsequent re-certification of their facility after it was relocated from North Sydney to Chatswood in Sydney. Additionally, he assisted with a 510k Submission to the FDA to enable export of the product to the USA.
2006 GAMBRO is a global leader in the development, manufacture and supply of kidney and liver dialysis equipment. Steve was engaged to perform an independent audit of Sypharma in Melbourne who manufacture drugs for use in Gambro dialysis machines.
The outcome of the audit recommended a number of improvements to the Sypharma QMS that were implemented to enable continuance of their facility to be approved by the Australian Therapeutic Goods Administration (TGA) and Gambro and an approved supplier.
2007-14 TeleMedCare 2007 Steve was offered the position of QA/RA Manager for TeleMedCare (TMC) in Sydney. The Australian company designed, manufactured and supported remote multiparameter health monitors for use in the home or a clinical setting.
The TMC monitor displayed ECG traces, blood pressure, oximetry and glucose, as well as spirometry (lung function), body temperature and weight measurement. TMC also developed a medication management software able to be downloaded to an off-the-shelf tablet pc that subsequently also supported wireless connected multi-parameter measurement devices.
Data from both platforms were able to be uploaded to offsite dual three tier secure servers accessible by the patient’s medical professionals to manage their health conditions remotely via a video link.
Steve established the QMS for TeleMedCare that included both hardware and software design controls and obtained TGA Product Quality Assurance Certification, the European CE Mark and US FDA 510k approval to market the health monitor in Australia, New Zealand, USA, Canada and the EU. Steve resigned from TeleMedCare when it was sold to a European organization in October 2014.
2015 LabStyle Innovations / DarioHealth is a global leader in digital health self-management solutions. They were developing the Dario™ Smart Diabetes Management Solution, a platform for diabetes management that combines an all-in-one blood glucose meter, native smart phone app, website portal and a wide variety of treatment tools to support more proactive and better informed decisions by users living with diabetes, their doctors and healthcare systems.
Steve provided initial regulatory guidance for the most appropriate conformity pathway to enable product certification and regulatory approval in Australia and the US.