• Together we innovate.
    You develop transformative medical devices.
    We develop strategies 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
Confidentiality
Confidentiality

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
March
16
2017

This conference will focus on unique insights and strategies to govern the 510(k) and PMA regulatory pathways, as well as what changes to expect with the implementation of the user fee reauthorization and FDA reforms. The program will provide valuable insight from a variety of perspectives and give companies submitting a 510(k) or PMA in the future, the tools they need to prepare successful submissions.

Mar 16 - Mar 17
Palo Alto, CA
  • Recent Events
  • Upcoming Events
J.P. Morgan 35th Annual Healthcare Conference
Jan 8 - Jan 11
San Francisco, CA
Dec 7 - Dec 8
San Jose, CA
Mar 16 - Mar 17
Palo Alto, CA
Apr 26 - Apr 28
Washington, DC