Proven Results Across Global Markets
Real success stories from companies we've helped achieve regulatory approval
Success Metrics
Numbers that speak for themselves
Client Satisfaction Rate
Regulatory Approvals Secured
Faster Average Time-to-Market
Critical Audit Findings
Markets (US, EU, India)
Expert Team Members
Featured Case Studies
In-depth look at how we helped clients succeed
Rapid FDA 510(k) Clearance for Cardiac Monitor
CardioTech Solutions
Medical Devices - Cardiovascular
United States
6 months
The Challenge
Startup needed FDA 510(k) clearance with complex predicate selection, incomplete DHF, and tight investor timeline.
Our Solution
Comprehensive gap analysis, optimal predicate identification, complete DHF development, biocompatibility testing coordination, detailed 510(k) submission preparation.
The Results
FDA clearance in 6 months (50% faster)|Zero major deficiencies|$5M Series A funding secured|98% complete documentation first submission
"Yuhitech strategic approach saved us time and money, bringing life-saving technology to patients faster."
EU MDR Compliance for IVD Platform
DiagnoTech Europe
In-Vitro Diagnostics
European Union
10 months
The Challenge
15 legacy IVD products needing IVDR transition with inadequate performance data and no ISO 13485:2016 QMS.
Our Solution
Product classification per IVDR, Clinical Performance Evaluation Reports for all products, ISO 13485 QMS implementation, complete Technical Documentation, Notified Body facilitation.
The Results
All 15 products transitioned|ISO 13485:2016 certified|CE Mark secured|Zero non-conformities|Market access maintained
"Yuhitech transformed our regulatory chaos into streamlined compliance. Their IVDR expertise was unmatched."
What Our Clients Say
"Yuhitech's expertise in navigating the FDA 510(k) process was exceptional. They helped us secure approval 3 months ahead of schedule. Their attention to detail and proactive communication made the entire process seamless. Highly recommended for any medical device company seeking US market entry."
"The transition from MDD to MDR was daunting, but Yuhitech guided us through every step. Their deep understanding of EU regulations and ability to translate complex requirements into actionable steps was invaluable. We achieved CE Mark certification without any major delays."
"Working with Yuhitech for our CDSCO drug registration was a game-changer. Their team's knowledge of Indian regulatory landscape and established relationships with authorities expedited our approval process. Professional, responsive, and results-driven."
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