About Vestech
Medical Device innovation and commercialisation is fraught with risk, missteps and wastage. Navigating the successful passage of a device from invention to commercial success is Vestech’s area of expertise. Understanding the landscape, working with innovators and providing collaborative advice are key components of our day to day activities.
Experience & Process
When it comes to Medical Device development and commercialisation, nothing beats experience. Vestech has that hands on experience and more. Vestech and its team have been in the field of medical device commercialisation for more than 30 years. During that time Vestech has accumulated direct and personal experience in the following areas:
The technical aspects of device design
The regulatory requirements
Intellectual property protection
Liaising with tertiary institutions
Business planning
Reimbursement strategies
Export development
International regulations and systems
Capital raising
Listed entities management
Legal requirements
Human resource development
Industry organisation engagement
Federal and state policy development and lobbying
Project management
Exit strategies
During the realisation of a medical device project, Vestech works with Australia’s top specialist vendors and consultants to assure a first class result. Vestech’s connections within Australia and Internationally have been built up and tested over decades to ensure “no surprises” delivery.
QED Medical provides regulatory, quality and general product development and manufacturing expertise to the medical device industry. The QED Mission is to measure, analyse and streamline projects and processes so that safe and effective, high quality medical products reach those in need of them as fast as possible and clients’ business may flourish.
Companies often come on a riddle when they intend to register their product in a region with higher ROI (return on investment) due to higher initial product registration process cost. At RQLogix we aim to assist our clients with optimum solutions to avoid regulatory submission pitfalls.
Most of the regulators / countries are accepting already registered products. These products are often low risk products and with increasing competition / low margin products. For higher classification and novel devices, the registration process require attention to detail and preparation, even these products are registered in overseas market. In the Australian market, they often get setback and face a lengthy registration process, if devices are selected for an application audit. Some class IIb devices and all class III devices require mandatory application audit.
Check our website to understand Australian regulatory requirements.
Our services are based on in-house highly knowledgeable professionals from the field of medical devices, pharmaceutical and biological sector.
We also pride our self in providing assistance to our clients with other regulatory avenues such as CE marking, EMA, US FDA, Health Canada and registration of products in New Zealand, Taiwan, Singapore, Japan and China.
Sydney, AU
Private
http://www.rqlogix.com.au
2 Employees
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