- 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.
- Quality SystemsWe ensure your compliance through
a customized approach.
- Pre-Clinical & Clinical ResearchWe design and run your studies to
produce high quality data.
- 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.
The 25th Annual Phoenix Conference will bring together top-level executives from large healthcare companies and CEOs of small, venture-backed firms for an opportunity to discuss critical issues of interest to the medical device industry today, as well as to network and gain valuable insights from both industry leaders and peers. This exclusive, two-day event will provide an unrivaled experience that will help inform and shape company strategy for the years ahead. Experien Group will be a presenting sponsor at this event.
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