• Together we innovate.
    You develop transformative medical devices. We develop regulatory pathways that work.
  • Expert Partner
    We are your senior strategist,
    Acting VP or regulatory representative.
  • Regulatory Affairs
    We define the pathway
    and deliver your major milestones.
  • Pre-Clinical & Clinical Research
    We design and run your studies to
    produce high quality data.
  • Quality Systems
    We ensure your compliance through
    a customized approach.
  • Biostatistics & Data Management
    We ensure data accuracy for your
    robust analyses.

Right path. Right strategy. Right partner.

Headquartered in Silicon Valley, our clients range from medtech
startups to industry giants. We integrate appropriate regulatory,
quality and clinical perspectives at all stages of the product life cycle.

Cutting edge
Cutting edge

Technology drives us. We lead programs for the most novel devices, IVDs, combination products, and mobile apps that are transforming medical care. Our experience covers every major area of clinical practice. Our involvement encompasses first-of-kind products as well as innovative, next generation technologies.

Track record

Results speak for themselves. We maintain exceptional clearance and approval rates for our clients’ U.S. and OUS premarket applications. We manage multiple submissions and lead numerous audits each and every month, covering a wide array of technologies. Our clients’ outcomes serve as our performance metric.

Track record

Intellectual property defines companies. Our business requires your utmost protection. Client proprietary information and privacy are rigorously maintained at all times. We strictly protect confidential information in all elements of our work.

Events to connect

We recognize the value of industry relationships and shared knowledge.
Whether presenting, participating on panels or attending to engage on
critical topics, we look forward to each opportunity to strengthen our
firm and contribute to the broader medical device ecosystem.

Next Event

Transcatheter Cardiovascular Therapeutics (TCT) is the world’s largest and most important educational meeting specializing in interventional cardiovascular medicine.

Oct 29 - Nov 2
Washington, DC
  • Recent Events
  • Upcoming Events
Oct 29 - Nov 2
Washington, DC
Dec 7 - Dec 8
San Jose, CA