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• Together we innovate.
  You develop transformative medical devices.
  We develop strategies that work.
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• Expert Partner
  We are your senior strategist,
  Acting VP or regulatory representative.
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• Regulatory Affairs
  We define the pathway
  and deliver your major milestones.
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• Quality Systems
  We ensure your compliance through
  a customized approach.
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• Pre-Clinical & Clinical Research
  We design and run your studies to
  produce high quality data.
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• Biostatistics & Data Management
  We ensure data accuracy for your
  robust analyses.
  Learn moreContact us

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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
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.

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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.

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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.

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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.

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• UPCOMING EVENTS

© 2016 Experien Group - All rights reserved.

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• Expert partner
• Regulatory affairs

• Quality systems
• Pre-clinical & Clinical
• Data & Biostatistics