Diapason: Your Comprehensive MedTech Consulting Boutique
At Diapason, we understand the complexities of designing, developing, and launching innovative medtech and wellness products. With over 20 years of experience, we provide comprehensive consulting services, guiding you through every stage of the process.
Our Services:
Design & Development: We offer tailored solutions to meet your design and development needs. We can act as a CTO-as-a-service to jumpstart your project, and help you build your development team both internally and externally, with access to a comprehensive network of vetted experts, both in Australia and abroad.
Regulatory Strategy: Navigating the medtech regulatory landscape can be daunting, but we're here to help you build a purpose-driven and agile strategy. We can also assist in preparing submission documents for various regulatory requirements.
Quality Management Systems (QMS): We help you develop efficient QMS that supports smooth processes while ensuring compliance with regulatory standards. Our services range from mentorship for early-stage entrepreneurs to conducting internal audits for established manufacturers.
Software as a Medical Device (SaMD): Our expertise extends to the development and compliance of SaMD, ensuring your software meets industry standards.
Research: We support evidence-driven progress through scientific literature reviews, competition analysis, KOL identification, and clinical partnerships.
Advisory: Our flexible advisory services provide strategic guidance tailored to your needs, helping you stay in control while maximizing efficiency.
No matter your current stage, our team at Diapason is dedicated to helping you bring your innovative medical product to market with confidence. Reach out today to discuss how we can support your medtech journey.