Elexes Medical Consulting

What Elexes Medical Consulting does

Elexes Medical Consulting is a private regulatory and quality compliance consulting firm focused exclusively on the medical device industry. The company was founded in 2015 and is led by Parul Chansoria (Founder and CEO) and Vivek Goyal (Co-Founder), with clinical and technical leadership from Dr. Mark Harman (Clinical Advisor) and Amit Padhy (Associate Tech Manager). The legal entity is registered as Elexes Medical Consulting Pvt. Ltd. in India, with US operational presence indicated by a Sheridan, US location and a +1 408-475-8091 contact line; the firm is reported to have 11-50 employees. Elexes markets itself as an end-to-end regulatory partner, claiming 50+ years of collective consultant experience, 200+ global premium clients, 250+ successful projects, and a 90% audits-cleared rate.

The firm's service portfolio covers the full medical device regulatory lifecycle: regulatory submissions across FDA (510(k), De Novo, PMA, Q-Sub, Breakthrough), EU MDR, EU IVDR, UK CA, Health Canada and TGA; quality system management (ISO 13485, ISO 15189, ISO 9001, MDSAP, CAPA, compliance audits); specialized support for SaMD, IVD/LDT, implants, wearables, combination devices and companion diagnostics; clinical evaluation reports; and post-approval surveillance. A parallel training and e-learning offering delivers regulatory and compliance education through videos and infographics. The underlying deliverable model is documentation, regulatory strategy, and authority liaison rather than a proprietary software platform.

Elexes runs a sales-led, enterprise-focused go-to-market: direct consultation, phone and email inquiry, multi-year project-based engagements, and quote-based pricing that varies by market, industry and product type. Marketing is content-led via the company blog, LinkedIn, YouTube, X, Medium, Facebook and Instagram, plus case studies and SEO, targeting medical device manufacturers, IVD and SaMD developers globally across North America, Europe, Asia-Pacific, the Middle East and Africa. The customer base spans enterprise medical device companies (Outset Medical, AliveCor, DJO Global, Niramai, Novasignal, Jana Care) and smaller specialty clients (Treedental, Liz Inc.), with named testimonials emphasizing responsiveness, technical depth and timeline-based delivery. No external funding, M&A, patents, awards, or regulatory actions are disclosed in available materials.

Name

Elexes Medical Consulting

Legal name

Elexes Medical Consulting Pvt. Ltd.

Website

https://elexes.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Elexes Medical Consulting is a private medical device regulatory and quality compliance consulting firm that helps manufacturers and SaMD/IVD developers secure FDA, EU MDR/IVDR, UK CA, Health Canada and TGA approvals, serving 200+ global clients through project-based engagements.

Ownership category

akta.pro rank

Headquarters

HQ city

Sheridan

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D

Revenue model

1. Regulatory Consulting Services: Professional consulting services providing regulatory strategy, submissions support, quality system management, clinical evaluation reports, and post-approval support for medical devices, IVDs, SaMD, and related products across global markets including FDA, EU MDR, TGA, Health Canada, and other regulatory jurisdictions.
2. Training and Education Services: Regulatory and compliance training services for medical device companies, including e-learning videos, infographics, and training programs aligned with FDA and ISO 13485 standards.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core offering

Elexes Medical Consulting is a regulatory and quality compliance consulting firm that helps medical device manufacturers navigate global regulatory approvals. Its offerings span end-to-end product lifecycle support: regulatory strategy and submissions (US FDA 510(k)/De Novo/PMA, EU MDR/IVDR, UK CA, Health Canada, TGA Australia), quality system management (ISO 13485, MDSAP, CAPA, audits), clinical evaluation reports, post-market surveillance, and regulatory and compliance training. The company specializes in device categories including SaMD, IVD/LDT, implants, wearables, combination devices, and companion diagnostics.

Product overview

Elexes Medical Consulting is a regulatory and quality compliance consulting firm offering a comprehensive portfolio of services for the medical device industry. The company provides end-to-end consulting spanning regulatory submissions (US FDA, EU MDR/IVDR, UK CA, Canadian, TGA Australia), quality system management (ISO 13485, MDSAP, compliance audits, CAPA), and specialized services for device categories including SaMD, IVD/LDT, implants, wearables, and combination devices. The core offering is regulatory strategy and submission support augmented by clinical evaluation reports, post-approval surveillance, and professional training. Services are delivered through experienced regulatory consultants who provide both advisory and execution support throughout the product lifecycle.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Regulatory Services Comprehensive regulatory and quality compliance support for medical device companies spanning the full product lifecycle — from product development and regulatory strategy through submissions and post-market compliance. Includes documentation support and covers all device classes (I, II, III). Targeted at medical device manufacturers seeking approvals across global markets.
• Regulatory Submission Services Multi-jurisdictional regulatory submission consulting covering US FDA (510(k), De Novo, PMA, Q-Submissions, Breakthrough Device Designation), EU MDR, EU IVDR, UK CA Marking, Health Canada, TGA Australia, and broader international regulatory authorities. Targeted at medical device and IVD manufacturers needing country-by-country approval support.
• IVD and LDT Regulatory Services Specialized regulatory consulting for in-vitro diagnostic (IVD) manufacturers and developers of Laboratory Developed Tests (LDTs), from IVD development stage through regulatory compliance and post-market services. Helps clients navigate the complex IVD regulatory landscape (IVDR/21 CFR Part 809 etc.) and ensures LDTs meet regulatory standards for reliable diagnostic results.
• Software as a Medical Device (SaMD) Regulatory Services Regulatory services for Software as a Medical Device (SaMD) and digital health products, covering SaMD classification, registration, regulatory gap analysis, IEC 62304 compliance, FDA software guidance navigation, and post-market compliance. Targeted at medical software developers and digital health companies.
• Implant and Wearable Medical Device Regulatory Services Regulatory consulting for implantable medical devices and body-worn medical devices (wearables) used for monitoring, diagnosis, or treatment. Addresses category-specific testing requirements and multi-jurisdiction regulatory strategy across FDA, CE, TGA, and Health Canada.
• Combination Device and Companion Diagnostic Regulatory Services Regulatory strategy and submission support for drug-device combination products (requiring compliance with both device and pharmaceutical regulations) and companion diagnostic products aligned with therapeutic product approvals. Targeted at combination product sponsors and developers of companion diagnostics.
• Quality System Management (QSR) Consulting Quality management system consulting aligned with FDA Quality System Regulation and international standards including ISO 13485 (medical device QMS), ISO 15189 (medical laboratory QMS), ISO 9001, and the Medical Device Single Audit Program (MDSAP). Supports regulatory compliance, certification, and inspection readiness for medical device manufacturers and laboratories.
• Compliance Audits and CAPA Consulting Internal and external regulatory compliance audit support (including gap identification) combined with Corrective and Preventive Action (CAPA) planning and implementation consulting. Targeted at medical device manufacturers preparing for or remediating regulatory inspections and findings.
• Clinical Evaluation Report (CER) Consulting Clinical Evaluation Report (CER) preparation and consulting services for medical devices, demonstrating safety and performance through clinical data assessment, literature reviews, and post-market clinical follow-up planning. Targeted at medical device manufacturers needing EU MDR-compliant CERs.
• Post-Approval and Post-Market Surveillance Support Post-market surveillance, vigilance reporting, and ongoing regulatory compliance support following product approval or clearance. Includes import/export regulatory support, labeling compliance, and registration maintenance. Targeted at approved medical device manufacturers needing continuous post-market compliance.
• Regulatory and Compliance Training Training programs and e-learning resources covering FDA regulations, ISO standards, EU MDR/IVDR, and global regulatory requirements for medical device industry professionals. Includes videos and infographics. Targeted at medical device company regulatory and quality teams needing structured upskilling.
• CE Marking Services End-to-end CE Marking consulting for European market access, covering regulatory strategy, technical documentation preparation, GSPR (General Safety and Performance Requirements) compliance, Notified Body liaison, and labeling/UDI compliance. Targeted at medical device manufacturers seeking European market entry.

Quantifiable outcome

• 90% audits cleared rate
• +2 more outcomes

Named customers20 records

Segments5 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key highlights7 records

Customer concentration

• Xx.com/ElexesInc?s=20
• YouTubeyoutube.com/channel/UClTxBYckmy1iFk19dO-7dKQ
• Facebookfacebook.com/elexesteam
• LinkedInlinkedin.com/company/elexes
• Instagraminstagram.com/elexes_medical_consulting/?hl=en

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Elexes Medical Consulting