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
**Who they are**
IQVVV is a provider of MedTech solutions specifically designed for the medical device and diagnostics industry. They support clients throughout the entire product lifecycle.
**Expertise & scope**
* Strategy and portfolio analysis
* Post-market procedures
* Commercialization support
**Reputation / proof points**
* Coverage includes EU, UK, CH, US, AU, and other regions.
IQVVV is a provider of MedTech solutions specifically designed for the medical device and diagnostics industry. They support clients throughout the entire product lifecycle.
**Expertise & scope**
* Strategy and portfolio analysis
* Post-market procedures
* Commercialization support
**Reputation / proof points**
* Coverage includes EU, UK, CH, US, AU, and other regions.
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
-
Supports medical device and diagnostics industry.
Source
“IQVVV MedTech solutions are purpose-built for the medical device and diagnostics industry”
-
Covers the entire product lifecycle.
Source
“spanning the entire product lifecycle from strategy and portfolio analysis to post-market procedures and commercialization.”
-
Global coverage including EU, UK, CH, US, AU, and other regions.
Source
“Coverage: EU, UK, CH, US, AU, OTHER”
Buyer Snapshot
Best for
- Medical device and diagnostics companies
- Companies seeking end-to-end product lifecycle support
How engagement typically works
- Project-based support
- Strategic partnership
Typical deliverables
- Regulatory strategy documents
- Market access plans
- Post-market surveillance reports
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
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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
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