IQVVV
IQVVV Inc.
IQVVV MedTech solutions are purpose-built for the medical device and diagnostics industry, spanning the entire product lifecycle from strategy and portfolio analysis to post-market.
About
IQVIA MedTech solutions are purpose-built for the medical device and diagnostics industry, designed with unique compliance needs in mind. As regulations governing medical devices and technology continue to evolve around the world, rigor and reproducibility in non-clinical, pre-clinical and clinical data - as well as the subsequent documentation - are essential.<br><br>From advice on strategies and portfolio analysis, to geographic-specific insights on regulatory authorities and revisions of post-market procedures, IQVIA's solutions span the entire product lifecycle. We support MedTech product development strategies, drive clinical studies, and provide connected commercial solutions to maximize market performance.<br><br>Our services include:<br>* A robust, yet agile, quality management system (QMS) that enables you to respond to auditor or management requests swiftly and accurately with quality data and insights.<br>* Adverse event reporting and post-market surveillance solutions that make vigilance easy and sustainable.<br>* Building a culture of quality in your organization that extends quality and compliance maturity and reduces cost of quality (COQ).<br><br>As a global leader in generating high-quality health data, advanced analytics, and clinical research, we help clients stay up to date with ever-changing regulatory requirements.
Additional information
IQVVV's MedTech solutions are tailored for the unique demands of the medical device and diagnostics sector. Their services encompass the full spectrum of product development and market entry, from initial strategic planning and portfolio assessment to navigating complex post-market requirements and achieving successful commercialization. They operate across multiple global regions, including the European Union, United Kingdom, Switzerland, the United States, and Australia.
Key Highlights
- Global expertise spanning clinical to commercial functions
- Solutions cover the entire product lifecycle
- Operates in over 100 countries
- Technology-driven solutions tailored for MedTech
- Network of over 250 pricing and market access experts
Certifications & Trust Signals
- Over 2,250 projects completed in pricing and market access
- Named a Leader in the 2023 Everest Group’s Life Sciences Sales and Marketing Operations PEAK Matrix® Assessment
- Partners with global health organizations like Europe’s HERA and The Global Fund
Buyer Snapshot
Best for
- Medical device and diagnostics companies
- Life sciences firms seeking global market access
- Organizations requiring end-to-end product lifecycle support
How engagement typically works
- Strategic consulting
- End-to-end project management
- Data and analytics services
Typical deliverables
- Market access strategies
- Quality Management System (QMS) implementation
- Portfolio analysis reports
- Post-market surveillance solutions
- Regulatory strategy documents
Good to know
- Best when requiring specialized MedTech expertise.
Facts
Examples & Achievements
IQVVV is working with Europe’s Health Emergency Preparedness and Response Authority (HERA), harnessing data to better identify and respond to future health threats. We helped define the appropriate real-world datasets to track Medical Countermeasure (MCM) supply chains, enabling the tracking of shortages and identification of potential vulnerabilities and strategic dependencies.
More about our services
Our Value and Access (V&A) Strategy Consulting helps define and defend product value across the entire lifecycle. We provide end-to-end support across the globe, leveraging proprietary data, technology, and advanced analytics to bring innovative therapies to patients. This includes developing pricing and market access strategies, integrating evidence requirements, and creating compelling value stories and communication tools.
HQ:
USA
Languages:
English
Claim status:
Claimed
Services & Capabilities
Importer & Distributor Compliance Support
Jurisdictions:
EU, UK, CH, US, AU, OTHER
Countries:
DE.FR
Industries:
MEDICALDEVICE
Portfolio:
6-25
Flags:
fast_onboarding, multi_language_support
Response SLA:
24 hours
Onboarding time:
1–3 days
Pricing model:
Retainer
Starting from:
USD 200
Training Available:
Yes
Template Pack Available:
Yes
Deliverables:
SOPs, Templates pack, Ongoing retainer, Audit support, Training
Training Format:
Live
Role Coverage:
Importer
510k_submission_services
Jurisdictions:
US
Countries:
US
Industries:
IVD
Portfolio:
6-25
Flags:
implantable, smd_samd, sterile, class_iii, ivd, high_risk_processing, high_portfolio
Response SLA:
24 hours
Onboarding time:
1–5 days
Pricing model:
Usage-based
Starting from:
USD 1,000
Services Offered:
Device Classification Support, Medical Device Reimbursement, 510(k) eSTAR Preparation, Traditional 510(k) Support, Abbreviated 510(k) Support, De Novo Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), PMA Strategy & Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Special 510(k) Support, 510(k) Strategy & Authoring, Regulatory Pathway Assessment, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), PMA, Abbreviated 510(k), Pre-Sub / Q-Sub, De Novo
Device Types Supported:
Medical device, IVD, SaMD, Combination product
Supports Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Years Experience:
13
Num510k Submitted:
500
Ex FDA:
Yes
Ex Notified Body:
Yes
Ex Big Medtech:
Yes
Accepting New Clients:
Yes
Typical Lead Time Weeks:
1
Response Time Hours:
24
us_agent_fda
Jurisdictions:
US
Countries:
GLOBAL
Industries:
FOOD.MEDICALDEVICE.COSMETIC
Portfolio:
26-100
Flags:
smd_samd, high_portfolio, high_risk_processing, implantable, sterile, measuring
Response SLA:
24 hours
Onboarding time:
1–2 days
Pricing model:
Retainer
Starting from:
USD 298
Product Type:
food, devices, drugs, cosmetics
Annual Renewal Support:
Yes
Registration Support:
Yes
Recall Support:
Yes
Time Zone Coverage:
US Central
Inspection Support:
Yes
Emergency Contact24x7:
Yes
Annual Renewal Reminder:
Yes
prrc_service
Jurisdictions:
EU
Countries:
EUWIDE
Industries:
MEDICAL
Portfolio:
6-25
Flags:
smd_samd, sterile, measuring, class_iii, ivd
Response SLA:
24 hours
Onboarding time:
1–3 days
Pricing model:
Retainer
Starting from:
USD 497
Named PRRC:
Yes
Availability Hours:
Business hours
Device Classes Supported:
Class I, Class IIb, Class Is/Im/Ir, Class III, Class IIa, IVD
eudamed_reg_support
Jurisdictions:
EU
Countries:
EU
Portfolio:
26-100
Flags:
fast_onboarding
Response SLA:
24 hours
Onboarding time:
1–3 days
Pricing model:
Retainer
Starting from:
USD 400
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, Clinical investigations, Vigilance, UDI/Devices, Certificates, Not sure
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
Same day
Additional importer_distributor_compliance Details
Role Coverage
importer, distributor
⚡ Instant booking available
Appoint a Vetted FDA U.S. Agent in 2 Minutes
Compare IQVVV and other vetted providers — instant pricing, no RFQ needed.
