(858) 876-LABS
Helping enable the next generation of medical technology innovators
About Us
Our Services
We provide consulting services in all disciplines of medical technology development, from PRDs, Regulatory strategies, Development phases (Hardware/Software) to Commercialization.
Our Consultants all come with between 15 and 30 years of experience both in regulated environments as well as fast-moving high-tech.
We can provide both comprehensive engagements for a new project or augment staff as necessary for on-going projects.
Our Approach
We start with a comprehensive consult to help identify overall strategy, gaps and opportunities and regulatory guidance.
We can then continue engaging at all levels of development and project/program management in hardware and software (firmware, web and mobile apps) as well as validation/verification support.
Why us?
The Medical device space is a complex one, with the added quality/reliability and documentation requirements. Prior experience and guidance in this area can provide the key differentiator for your product.
We want to help push the envelope on consumer and wearable medical technology and are keen to work with startups providing the same level of service as a high-end consultancy for a fraction of the cost.