Consulting services for Medical Devices including MDSW, SaMD, DTx and AI/ML-Enabled solutions
Medigear Innovations was founded to address the growing need for expertise in the dynamic field of Medical Devices, particularly focusing on Medical Device Software (MDSW), Software as a Medical Device (SaMD), Digital Therapeutics (DTx), and AI/ML-enabled solutions. We employ a pragmatic and structured approach to streamline the path to market, minimizing burdens without compromising on our top priorities: patient safety and product quality.
We provide the following services:
Regulatory Strategy
Whether seeking FDA approval, CE or UKCA marking for your medical device, we can provide you with support in both regulatory strategy, submission and interaction with regulatory authorities.
Clinical Development
With several years of experience within Medical Writing and Good Clinical Practice, we can support your Clinical Evaluation including Clinical Development and strategy.
Quality Assurance
We provide Design Assurance services covering all aspects of Design Control, as well as Quality Assurance and Audit support in the development of your Quality Management System (QMS).
Why MediGear Innovation Consulting?
To bring your medical device to market as smoothly as possible you need someone who truly understands the regulatory framework, relevant standards and your technology.
Regulatory experience
During their time working at the Therapeutic Goods Administration (TGA), our team not only learned how the TGA framework operates, they also gained firsthand experience in interpreting the Australian requirements for medical devices.
Digital, software & innovation
Members of our team led regulatory reform for the TGA relating to cybersecurity and emerging technology, and specialized in applying the regulation to novel and innovative products.
Medical device & government expertise
Our team has experience writing both regulations and standards for medical devices and related technology (e.g. the Internet of Things). So, we have a deep understanding of how standards are developed, interpreted and applied as well as how regulators operate and do business. This is invaluable knowledge when assisting our clients navigate the complex approval process.
Technology designers
Our team are experienced researchers, designers and developers, and Platypus MedTech Consulting is an established technology company, so we understand the medical science and engineering behind your product, and have the critical expertise in product validation.