Crafting unique pathways to market
Discover the story behind TMT Consulting, our passion for innovation, and our unwavering commitment to guiding you through complex medical device and pharmaceutical regulations.
Our unique approach to regulatory challenges
TMT Consulting was founded to assist businesses with products in the 'grey areas' of regulation. We are passionate about working with unique and novel products that may not perfectly fit existing regulations. With over 30 years of team experience, we aim to overcome the stigma that regulatory bodies only say no. We strive to find the most business-appropriate pathway, considering both risk and business value, to bring your product to market or keep it there. We understand the nuances of FDA 510k, PMA, CE Marking, Health Canada, and Australian TGA approvals, and our expertise ensures efficient and compliant solutions.
Dedicated, consistent and cutting-edge service
At TMT Consulting, we are dedicated to providing hands-on customer service. Your consultant is exclusively yours; we do not subcontract or change consultants during your engagement with us. We are committed to delivering consistent, unique, and cutting-edge service, ensuring you always feel supported and well-informed throughout the regulatory and quality process. Our goal is to optimise your business’ technical documentation, including risk management, design documentation, clinical trials, and clinical evaluation reports.
Leveraging unparalleled experience for your success
With over 30 years of industry experience, the TMT Consulting team has a proven track record of working closely with regulators, many of whom have personally requested our services. Our extensive experience spans thousands of different products, including numerous novel technologies. This vast practical knowledge allows us to apply unique insights to your product opportunities, ensuring fast regulatory approvals and speed-to-market. Whether you're a start-up or a large multinational, our expertise in medical devices, pharmaceuticals, and in vitro diagnostics is tailored to your company's specific needs.
"TMT Consulting provided the clarity and direction we desperately needed for our novel product. Their personalised approach made all the difference."
-Anonymous [feedback at project conclusion]