Toggle navigation
Right path. Right strategy. Right partner.
- Together we innovate.
You develop transformative medical devices.
We develop strategies that work.
Learn moreContact us- Expert Partner
We are your senior strategist,
Acting VP or regulatory representative.
Learn moreContact us- Regulatory Affairs
We define the pathway
and deliver your major milestones.
Learn moreContact us- Quality Systems
We ensure your compliance through
a customized approach.
Learn moreContact us- Pre-Clinical & Clinical Research
We design and run your studies to
produce high quality data.
Learn moreContact us- Biostatistics & Data Management
We ensure data accuracy for your
robust analyses.
Learn moreContact us
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.
Learn more
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.
Learn more
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.
Learn more
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.
- RECENT EVENTS
- UPCOMING EVENTS
© 2016 Experien Group - All rights reserved.
- Forums
- ASX - By Stock
- RAP
- Ann: Update on Australian Adult Study and FDA De Novo Submission
Ann: Update on Australian Adult Study and FDA De Novo Submission, page-10
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
-
- There are more pages in this discussion • 95 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)