- Together we innovate.You develop transformative medical devices.
We develop strategies that work.
- Expert PartnerWe are your senior strategist,
Acting VP or regulatory representative.
- Regulatory AffairsWe define the pathway
and deliver your major milestones.
- Pre-Clinical & Clinical ResearchWe design and run your studies to
produce high quality data.
- Quality SystemsWe ensure your compliance through
a customized approach.
- Biostatistics & Data ManagementWe ensure data accuracy for your
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.
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.
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.
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.
Attendees will obtain sophisticated and actionable insights into the critical technology and business issues facing the development and deployment of digital health devices, tools, and services. In its inaugural year, the Conference will offer insights into the current and future challenges, opportunities and trends in the digital health space. Bringing together leading experts and innovators from across the industry, this one-day event will also provide unparalleled access to key decision-makers. Anchored by its timely and robust programming, panels will offer unmatched content to guide digital health decisions.
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