- 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.
Medtech Disruption: The Impact of AI on Medicine.
Is AI going to replace doctors?…We don’t think so either. But 75% of executives believe it’s going to transform their business in the next 3 years. What is AI? How is it impacting healthcare and the medtech industry? Join us to learn what’s real, what’s hype and how AI might affect your business in the digital era of medicine. Please join us at this conference where Experien Group's Chief Strategy Officer, Nada Hanafi, will be interviewed and Experien Group's VP of Business Development & Marketing, Jessica Richter, will be the MC.
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