Maven Profcon Services
Maven Profcon Services LLP
Verified
★★★★★
4.7
/ 5
•
94 reviews
Global Medical Device Regulatory Consultants for FDA 510(k), EU MDR, EU IVDR, ISO 13485, QMSR & MDSAP
Maven ProfServ is a dedicated consulting firm specializing in FDA 510(k) regulatory support for global medical device manufacturers. With 12 years of experience, they offer expert assistance for traditional 510(k) submissions for Class I and Class II medical devices, with a strong focus on In Vitro Diagnostic (IVD) products. Maven ProfServ is committed to helping medical device companies successfully navigate FDA regulatory pathways and achieve timely clearances.
About
Maven Profcon Services is a dedicated consulting firm specialising in FDA 510(k), EU MDR, EU IVDR, ISO 13485, QMSR, and MDSAP regulatory support for global medical device manufacturers. With more than 10 years of experience, we offer expert assistance with traditional 510(k), EU MDR & EU IVDR submissions for Class I, Class II and Class III medical devices. Maven is committed to helping medical device companies successfully navigate US & EU regulatory pathways and achieve timely clearances.
Additional information
With more than a decade of experience in the medical device regulatory industry, we have successfully delivered projects across a broad spectrum of medical devices, ranging from low-risk to high-risk classifications. Our practical regulatory strategies, timely deliverables, and deep industry knowledge help streamline the approval process, enabling faster market access of the product while minimizing delays and reducing overall time-to-market costs.
Certifications & Trust Signals
- Served more than 350 customers globally
Buyer Snapshot
How engagement typically works
- End-to-end service
- Handholding service from the preparation of Technical Documentation till certification
Good to know
- Working on software to avoid manual errors
- Quick turnaround time
Facts
Examples & Achievements
- US FDA 510(k), EU MDR & EU IVDR experts
- Served more than 350 customers globally
- A great expert regulatory consultant team of more than 100
- More than a decade in Medical Device Regulatory Consulting
- Automated workflows with proprietary software for documentation
- Served more than 350 customers globally
- A great expert regulatory consultant team of more than 100
- More than a decade in Medical Device Regulatory Consulting
- Automated workflows with proprietary software for documentation
More about our services
We offer comprehensive support for FDA 510(k), EU MDR, EU IVDR, ISO 13485, QMSR, and MDSAP, including detailed scope of work and minimum delivery timelines.
HQ:
Ahmedabad, India
Website:
mavenprofserv.com
Public email:
enquiry@mavenprofserv.com
Phone:
+91 7600437774
Languages:
English
Timezones:
GMT, CET
Access:
Verified
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US, EU, UK, CH, AU, JP, BR, Global
Countries:
United States, United Kingdom, Germany, France, Netherlands, Italy, United Arab Emirates, Spain, Switzerland
Industries:
Medical Devices, IVD
Portfolio:
100+, 26-100, 6-25, 1-5
Response SLA:
48 hours
Onboarding time:
3–5 days
Pricing model:
Custom pricing
Starting from:
USD 500
Included services:
UDI support, EUDAMED registration
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, 510(k) eSTAR Preparation, Special 510(k) Support, Abbreviated 510(k) Support, Traditional 510(k) Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), Pre-Sub / Q-Sub
Device Types Supported:
IVD, Medical device, SaMD, Combination product, Other
Supports Estar:
Yes
Supports Rta Remediation:
No
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Years Experience:
10
Num510k Submitted:
50
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Engagement Models:
custom, fixed
Accepting New Clients:
Yes
Typical Lead Time Weeks:
4
Response Time Hours:
48
