- Together we innovate.You develop transformative medical devices. We develop regulatory pathways 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.
10th annual BIOMEDevice San Jose showcases emerging trends and innovations that will set the tone for the biomed industry in 2017 and beyond in a two-day Connected Health Device Development Summit. With thousands of attendees, more than 300 leading exhibitors, and numerous thought leaders set to meet face-to-face, BIOMEDevice San Jose is a must-attend opportunity for medtech professionals to accelerate industry knowledge and network.
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