Med Device
MedDeviceCorp is a privately held regulatory affairs consulting firm that helps medical device, pharmaceutical, food, nutraceutical, and cosmetics manufacturers achieve EU MDR/IVDR CE marking, FDA 510(k) clearance, ISO 13485 certification, and country-specific registration across more than eight global markets.
- Company typePrivate
- Founded-
- HeadquartersCharlotte, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Med Device does
MedDeviceCorp is a privately held regulatory affairs consulting firm headquartered in Charlotte, NC, that delivers end-to-end compliance and market-access services for manufacturers of medical devices, pharmaceuticals, food, nutraceuticals, and cosmetics. The firm supports clients across more than 20 service lines spanning EU MDR/IVDR CE marking, FDA 510(k) submissions, ISO 13485 quality management system certification, MDSAP, post-market surveillance, biocompatibility consulting, and country representation (EU Authorized Representative, UK Responsible Person, US Agent, Indian Agent). Project execution is supported by a cloud-based documentation platform that enables clients worldwide to access, monitor, and direct technical file development 24/7, with a designated India engineering and delivery hub (Bangalore) housing the CER writing, QA/RA, and project management teams.
The company operates a professional services revenue model priced by device risk class and service tier. Clinical Evaluation Report (CER) services are offered in three tiers (Regular, Premium, Assured) ranging from $4,999 to $14,999 for Class III devices, while EU Authorized Representative annual fees range from €850 (Class I) to €1,350 (Class III). Drug-device combinations and active implantables carry a 40% surcharge. New business is captured primarily through self-serve RFQ/RFP forms on the website, supported by an inside sales team reachable via country-specific phone numbers across the USA, India, UK, Vietnam, Malaysia, and Germany, with proposals typically delivered within 4-8 hours.
MedDeviceCorp serves a horizontal customer base of 2,300+ manufacturers across more than eight jurisdictions, with no disclosed anchor customers. Go-to-market relies on content marketing via its ShareThoughts blog, organic social (Facebook, X, Instagram), email outreach, and direct inside sales. The firm was previously known as I3CGlobal and has expanded its global footprint to include offices in the UK, Germany, South Korea, Malaysia, Vietnam, and Australia, in addition to its US and India hubs.
Med Device firmographics
Firmographics- Name
- Med Device
- Legal name
- MedDeviceCorp
- Website
- https://meddevicecorp.com
- Company type
- Private
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- MedDeviceCorp is a privately held regulatory affairs consulting firm that helps medical device, pharmaceutical, food, nutraceutical, and cosmetics manufacturers achieve EU MDR/IVDR CE marking, FDA 510(k) clearance, ISO 13485 certification, and country-specific registration across more than eight global markets.
- Ownership category
- akta.pro rank
Med Device industry classification
Industry- Product category
- Regulatory Affairs Consulting
- NAICS
- Other Scientific and Technical Consulting Services (54169), Scientific Research and Development Services (5417)
- SIC
- Services-Health Services (8000), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)
- akta.pro secondary industry
- Clinical Trials Authorization & Oversight (GCP) (HLAJADAF)
Keywords
Where Med Device is headquartered
LocationHeadquarters
- HQ city
- Charlotte
- HQ country
- United States
- HQ region
- North America
Offices8 records
Markets served
Med Device business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales
Revenue model
- Regulatory Affairs Consulting Services: The company earns revenue through consulting fees for regulatory compliance services including CE Marking, FDA 510(k), ISO 13485 certification, and related regulatory submissions. Fees are structured by device risk class and service tier (Regular, Premium, Assured), with professional services delivered across engagement lifecycle from gap analysis through Notified Body submission and approval.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Annual | EU Authorized Representative Annual Service Fee - Class I Medical Devices |
| Unit Pricing | Annual | EU Authorized Representative Annual Service Fee - Class Is, Im, Ir, IIa |
| Unit Pricing | Annual | EU Authorized Representative Annual Service Fee - Class IIb |
| Unit Pricing | Annual | EU Authorized Representative Annual Service Fee - Class III |
| Unit Pricing | Multi-year contract | Free Sale Certificate |
| Unit Pricing | Multi-year contract | Competent Authority Registration |
| Unit Pricing | Multi-year contract | E.A.R Certificate Attestation from Chamber of Commerce |
| Subscription | Multi-year contract | CER Regular Tier - Class III |
| Subscription | Multi-year contract | CER Premium Tier - Class III |
| Subscription | Multi-year contract | CER Assured Tier - Class III |
| Subscription | Multi-year contract | CER Regular Tier - Class IIb |
| Subscription | Multi-year contract | CER Premium Tier - Class IIb |
| Subscription | Multi-year contract | CER Assured Tier - Class IIb |
| Subscription | Multi-year contract | CER Regular Tier - Class IIa |
| Subscription | Multi-year contract | CER Premium Tier - Class IIa |
| Subscription | Multi-year contract | CER Assured Tier - Class IIa |
Go-to-market motion1 record
Distribution channels3 records
Marketing channels6 records
Med Device product offering
Product offeringCore offering
MedDeviceCorp provides regulatory affairs consulting and support services to manufacturers of medical devices, pharmaceuticals, food, nutraceuticals, and cosmetics seeking market access and ongoing compliance across the EU, US, UK, and APAC. The firm delivers turnkey regulatory projects spanning gap analysis, technical documentation, Clinical Evaluation Reports, Notified Body submissions, and post-market surveillance. Engagements are executed via a cloud-based documentation platform that gives clients 24/7 visibility into project status and enables remote direction of missing data.
Product overview
MedDeviceCorp is a regulatory affairs consulting firm offering a comprehensive portfolio of regulatory compliance services for healthcare product manufacturers. The company's service offerings span multiple regulatory frameworks including EU MDR/IVDR CE marking, US FDA 510(k) and registration, ISO 13485 quality management systems, and international market representation. Key service modules include: Clinical Evaluation Report preparation and consultation, Post Market Surveillance planning, EU/UK/US country representation services, and specialized support for biocompatibility testing, drug master files, and GMP certification. The firm positions itself as a full-service regulatory partner handling documentation preparation, Notified Body submissions, and ongoing compliance maintenance rather than a traditional software product company.
Differentiator
Problem solved
Functional benefit
Products and services
- MDR CE Marking Services Regulatory consulting for Medical Device Regulation 2017/745 compliance, guiding manufacturers through the CE marking process for EU market access.
- IVDR CE Marking Services Regulatory consulting for In Vitro Diagnostic Device Regulation 2017/746 compliance for IVD manufacturers seeking CE marking.
- FDA 510(k) Consulting Services Premarket notification consultation and submission support for FDA 510(k) clearance process in the US market.
- FDA Registration Services US FDA facility registration services for drugs, medical devices, food, supplements, and cosmetics manufacturers.
- ISO 13485 Certification Consulting Quality Management System implementation and certification support for EN ISO 13485 standard compliance.
- Clinical Evaluation Report (CER) Services Document preparation and consultation for clinical evaluation reports required under EU MDR, including literature search protocols and equivalence demonstrations. Three pricing tiers (Regular, Premium, Assured) per device risk class include Stages 0-4 development, with Premium and Assured adding Notified Body coordination and resubmission support until approval.
- EU Authorized Representative Services European Authorized Representative (EAR/EC Rep) services for non-EU manufacturers, including EUDAMED registration, UDI assignment, and Free Sale Certificate procurement. Annual fees range from €850 (Class I) to €1,350 (Class III).
- UK Responsible Person (UKRP) Services UK Responsible Person services for MHRA registration and UKCA marking compliance for non-UK manufacturers.
- Post Market Surveillance (PMS) Services Post-market surveillance and PMCF plan development to meet ongoing MDR compliance requirements for medical devices.
- Biocompatibility Testing Services Consultation and guidance for biological risk assessment and biocompatibility testing requirements for medical devices.
- Drug Master File Services FDA Drug Master File preparation and submission support for active pharmaceutical ingredients and drug products.
- GMP Certification Consulting Good Manufacturing Practice facility design and certification consultation services.
- MDSAP Certification Services Medical Device Single Audit Program certification support for manufacturers seeking multi-country market access.
- FDA QSR Certification Services FDA Quality System Regulation (21 CFR Part 820) compliance and certification support.
- US FDA Agent Services US Agent representation services for foreign manufacturers required for FDA registration and listing.
- India Agent Services Indian regulatory agent services for medical device registration and compliance in the Indian market.
Quantifiable outcome
- 2,300+ customers served with timely delivery
- +2 more outcomes
Companies that use Med Device
Customer profileSegments3 records
Ideal customer profiles3 records
Med Device technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature1 record
Med Device partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- EU Notified BodiescoreMedDeviceCorp works with EU Notified Bodies designated by European member state governments to conduct independent conformity assessments under MDR 2017/745 and IVDR 2017/746. The company manages the technical file submission, coordinates review processes, and handles Notified Body feedback and resubmissions on behalf of client manufacturers. MedDeviceCorp takes 'turnkey projects' placing business with Notified Bodies on behalf of clients.
Scale indicators1 record
Recent moves6 records
Expansion highlights5 records
Med Device competitors and assessment
Company assessmentBroad incumbents
- IQVIA (Regulatory & Quality): IQVIA offers regulatory affairs and quality consulting for medical devices and pharmaceuticals as part of its large CRO and data services portfolio. It is a broad incumbent with significant global reach.
- Parexel International: Parexel is a global CRO that provides regulatory affairs consulting alongside clinical research and commercialization services. It serves medical device and pharmaceutical clients as part of a much broader portfolio.
- NSF International (Health Sciences): NSF provides medical device regulatory consulting, testing, certification, and training services globally. It is a broader incumbent offering overlapping services as part of a wider portfolio of health sciences and compliance services.
- NAMSA: NAMSA is a medical device-focused CRO offering regulatory affairs consulting, clinical research, and testing services. It is a broader incumbent with overlapping regulatory services alongside its larger clinical and laboratory portfolio.
- BSI Group (Medical Devices): BSI is a leading Notified Body and standards organization that provides CE marking certification, ISO 13485 certification, and related regulatory consulting. It is a broad incumbent with significant overlap in MDR/IVDR services.
- TÜV SÜD (Healthcare & Medical Devices): TÜV SÜD is a major Notified Body and testing/consulting organization that provides EU CE marking, ISO 13485, and FDA-related support. It is a broad incumbent and is also a Notified Body MedDeviceCorp works with on client submissions.
Emerging players
- Greenlight Guru: Greenlight Guru provides QMS and regulatory submission software for medical device companies, including document management, design controls, and submission support. It represents an emerging software-enabled alternative to pure consulting services.
Direct peers
- Regulatory & Quality Solutions (R&Q): R&Q is a regulatory and quality consulting firm specializing in medical devices and combination products, offering CE marking, FDA 510(k), ISO 13485, and quality system services. It is a direct competitor with overlapping service lines and customer base.
- Maetrics: Maetrics provides regulatory affairs, quality, and compliance consulting for medical device and pharmaceutical manufacturers, with deep expertise in EU MDR, FDA submissions, and ISO standards - directly comparable to MedDeviceCorp's core offering.
- Medidee Services: Medidee is a Switzerland-based medical device regulatory and quality consulting firm offering CE marking, Notified Body support, clinical evaluation, and ISO 13485 services. Comparable in focus and size to MedDeviceCorp.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights7 records
Customer concentration
Med Device social profiles
Digital presenceMed Device financial estimates
Financial estimateRevenue estimate
Valuation estimate
Med Device leadership team
Management profileNumber of profiles
Profiles1 record
Med Device funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Med Device M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Med Device
What does Med Device do?
MedDeviceCorp provides regulatory affairs consulting and support services to manufacturers of medical devices, pharmaceuticals, food, nutraceuticals, and cosmetics seeking market access and ongoing compliance across the EU, US, UK, and APAC. The firm delivers turnkey regulatory projects spanning gap analysis, technical documentation, Clinical Evaluation Reports, Notified Body submissions, and post-market surveillance. Engagements are executed via a cloud-based documentation platform that gives clients 24/7 visibility into project status and enables remote direction of missing data.
Is Med Device a public or private company?
Med Device is a private company. It is classified as unknown and is currently operating.
When was Med Device founded?
Med Device was founded in -1. It employs 11 to 50 people.
Where is Med Device based?
Med Device is headquartered in Charlotte, United States, in the North America region.
How does Med Device make money?
One revenue line is on record: regulatory Affairs Consulting Services.
Who are Med Device's main competitors?
Broad incumbents on record are IQVIA (Regulatory & Quality), Parexel International, NSF International (Health Sciences), NAMSA, BSI Group (Medical Devices) and TÜV SÜD (Healthcare & Medical Devices). Greenlight Guru is listed as an emerging player. Direct peers are Regulatory & Quality Solutions (R&Q), Maetrics and Medidee Services.
Does Med Device have an API?
No public API is recorded for Med Device.
What industry is Med Device in?
Med Device's product category is Regulatory Affairs Consulting. Its primary akta.pro industry code is HLAGAJAM, Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF), with a secondary code of HLAJADAF, Clinical Trials Authorization & Oversight (GCP). Its NAICS code is 54169 and its SIC code is 8000.