Jalex Medical

What Jalex Medical does

Jalex Medical is a privately held medical device consulting firm headquartered in Westlake, Ohio, operating as a subsidiary of Thogus, a diversified Ohio-based contract manufacturing group, since 2012. The firm delivers integrated design engineering, regulatory affairs, quality management, project management, and risk management services for Class I and Class II FDA-regulated medical devices, with depth across 20+ medical specialties including orthopedics, spine, neurology, sports medicine, extremities, gynecology, urology, trauma, and dental. Its core operating model is an under-one-roof structure that combines design engineering, regulatory affairs (510(k), De Novo, PMA, CE marking, Health Canada), and quality management systems (ISO 13485, FDA 21 CFR Part 820, ISO 14971), reducing handoff friction and compressing timelines; over 13+ years the firm has supported 100+ device programs and achieved 60+ FDA clearances with an average FDA review period of approximately 98 days. Specialized capabilities include 15+ cadaveric lab engagements for design iteration and a dedicated Project Rescue service for stalled programs.

The business operates as a B2B professional services firm with a sales-led GTM anchored on direct outreach, industry conference presence (AAOS, NASS, OMTEC, MD&M West), referral networks seeded through Plug and Play Cleveland, mHUB, MedTech Innovator, and Midwest Pediatric Device Consortium engagements, and thought leadership via President Jennifer Palinchik. Revenue is generated through project-based, custom-scoped consulting engagements billed to a client mix that spans pre-revenue medical device startups and Fortune 500 medical device OEMs; named clients include Centerline Biomedical, RTsafe, Omnia Medical, Invibio Biomaterial Solutions, and Prichard Medical. Pricing is quote-based per engagement with no publicly disclosed tiers, and the firm offers free initial consultations to drive top-of-funnel inquiries. The organization fields roughly 12-20 named staff plus active hiring for Quality & Regulatory Engineer and Project Engineer roles, executes under multi-year contracts, and has not raised external funding.

Name

Jalex Medical

Legal name

JALEX Medical, LLC

Website

https://jalexmedical.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

11–50 employees

Short description

Jalex Medical is a Westlake, Ohio-based medical device consulting firm that provides integrated design engineering, regulatory affairs, and quality management services to Class I and Class II device companies, serving startups, surgeon inventors, and Fortune 500 OEMs across 20+ specialties since 2012.

Ownership category

akta.pro rank

Product category

Medical Device Consulting Services

NAICS

Other Scientific and Technical Consulting Services (541690)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

akta.pro secondary industry

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)

Keywords

• Medical device design
• Regulatory affairs consulting
• Quality management systems
• FDA 510(k) submissions
• Medical device engineering

Headquarters

HQ city

Westlake

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. Medical Device Consulting Services: JALEX generates revenue through professional services fees for design engineering, regulatory affairs consulting, quality management system development, and project management. Services are billed project-based or through consulting engagements, serving clients from startups to Fortune 500 medical device manufacturers. The company operates on a quote-based, client-by-client pricing model with no publicly disclosed standard pricing.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels7 records

Core offering

Jalex Medical provides integrated medical device design, engineering, regulatory affairs, and quality management consulting services for Class I and Class II FDA-regulated devices. The firm delivers full-lifecycle support from concept through FDA clearance and commercialization, combining design engineering, regulatory submissions (510(k), De Novo, PMA), quality management system development, project management, and project rescue services for stalled programs under a single cross-functional team.

Product overview

JALEX Medical is a medical device consulting firm offering integrated engineering, quality, and regulatory services through a unified platform. Their core portfolio consists of six interconnected services: Medical Device Design (full-service device engineering from concept through production-ready designs), Regulatory Affairs Consulting (FDA 510(k), PMA, De Novo, and international regulatory pathway navigation), Quality Management Systems (ISO 13485 and FDA 21 CFR Part 820 compliant QMS development and maintenance), Project Management (full lifecycle oversight with cross-functional coordination), Project Rescue (recovery services for stalled programs), and Risk Management (ISO 14971 compliance). All services are delivered by in-house cross-functional teams working under one roof, enabling seamless handoffs from concept through commercialization.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Design Full-service design and product development engineering for medical devices, including concept generation, 3D CAD modeling, prototype evaluation, manufacturability assessment, materials selection, and design control documentation. Targeted at medical device companies, OEMs, and surgeon inventors developing Class I and Class II devices.
• Regulatory Affairs Consulting Regulatory pathway navigation and submission preparation for FDA 510(k), PMA, and De Novo pathways, as well as international submissions including CE marking and Health Canada approvals. Targeted at medical device companies seeking regulatory clearance for Class I and Class II devices.
• Quality Management Systems Design, implementation, and maintenance of quality management systems compliant with FDA QSR 21 CFR 820 and ISO 13485, including audit support, risk management, and training. Targeted at medical device companies establishing or remediating QMS processes.
• Project Management Full lifecycle oversight of medical device development projects, coordinating cross-functional teams, managing timelines and budgets, and ensuring deliverables meet regulatory requirements. Targeted at medical device companies needing structured program leadership across the development cycle.
• Project Rescue Specialized analysis and recovery services for stalled medical device projects, diagnosing gaps in design controls, testing, quality documentation, and regulatory strategy, then implementing disciplined recovery plans. Targeted at medical device companies with delayed or at-risk development programs.
• Risk Management Risk management services compliant with ISO 14971, including hazard identification, risk analysis, and implementation of effective mitigation strategies for medical device companies across the development lifecycle.

Quantifiable outcome

• ~98 days average FDA 510(k) review period
• +6 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• RTsafecoreStrategic or Co-development Partner · 1 January 2017JALEX Medical partnered with RTsafe (Greek-based company) in 2017 as their US-based regulatory consultants. The partnership led to 510(k) FDA clearance for RTsafe's Personalized PseudoPatient dosimetry phantoms used in radiotherapy treatment. RTsafe came to Ohio via the SelectUSA program, and JALEX president Jennifer Palinchik served as featured speaker and mentor during the Cleveland SelectUSA event.
• Centerline BiomedicalcoreStrategic or Co-development PartnerCenterline Biomedical, a Cleveland Clinic Innovations spinout, partnered with JALEX Medical as their quality and regulatory department. JALEX supported design controls, 510(k) submission, and initial QMS development. FDA clearance was achieved 5 months ahead of schedule during a federal government shutdown. JALEX later transitioned to a supporting role providing post-market regulatory and quality support.
• Omnia MedicalcoreStrategic or Co-development PartnerJALEX Medical partnered with Omnia Medical on product development and regulatory activities for the first PEEK-OPTIMA HA Enhanced Vertebral Body Replacement (VBR) system to receive FDA 510(k) clearance in the US market. This was a three-way collaboration including Invibio Biomaterial Solutions who provided the biomaterial.
• Invibio Biomaterial SolutionscoreStrategic or Co-development PartnerInvibio Biomaterial Solutions (Victrex plc company) collaborated with JALEX Medical and Omnia Medical on the PEEK-OPTIMA HA Enhanced VBR system. Invibio provides the PEEK-OPTIMA polymer biomaterial, while JALEX handled product development and regulatory activities.
• Prichard MedicalminorStrategic or Co-development PartnerOrthopedic device company founded by Dr. Joseph Drain. JALEX partnered to provide regulatory strategy and FDA clearance support for Dr. Drain's orthopedic device prototype. Dr. Drain was referred to JALEX through an entrepreneurial support organization in Cleveland.
• ThoguscoreOthersJALEX Medical was acquired by Thogus in 2012. Thogus is a family-owned plastic injection molder headquartered in Avon Lake, Ohio, that evolved into a diversified contract manufacturing group. Under Thogus, JALEX operates as part of a group of complementary businesses including rp+m (additive manufacturing, founded 2009) and Proto Plastics Inc (acquired 2019), serving clients from consumer products to military aircraft.
• MedTech InnovatorminorGTM or Marketing PartnerJALEX President Jennifer Palinchik participated as a judge in MedTech Innovator's 2021 Road Tour Pitch Event for the Pain Medicine, Orthopedics, Cardiology, Vascular, and Interventional Track. JALEX engages with the MedTech Innovator ecosystem for networking and startup visibility.
• Plug and Play ClevelandminorGTM or Marketing PartnerJALEX President Jennifer Palinchik served as a mentor and industry expert at Plug and Play Cleveland, a technology accelerator and innovation platform, at the Global Center for Health Innovation.
• mHUB / Project MedTech MidwestminorGTM or Marketing PartnerJALEX participated as a featured speaker and exhibitor at the Project MedTech Midwest Showcase at mHUB Chicago. JALEX President Jennifer Palinchik spoke on a panel about navigating the medical device development process.
• Midwest Pediatric Device Consortium (MPDC)minorGTM or Marketing PartnerJALEX Medical sponsored the MPDC Showcase at The Ohio State University. MPDC is an FDA-funded initiative led by Nationwide Children's Hospital, OSU, Cincinnati Children's, and Cleveland Clinic Children's to advance pediatric device development. JALEX's sponsorship supports the innovation ecosystem.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• NAMSA: North American Science Associates is the largest medical device-focused CRO, offering regulatory, clinical, and laboratory testing services for Class I–III devices — directly overlapping with JALEX's regulatory affairs and QMS consulting for Class I/II devices.
• Regulatory & Clinical Research Institute (RCRI): Minneapolis-based regulatory and clinical consulting firm serving medical device OEMs with FDA submission, QMS, and clinical study services — same buyer, same service mix, and similar project-based engagements to JALEX.

Broad incumbents

• BSI Group: Global certification body with a dedicated medical devices practice covering ISO 13485 QMS certification and CE Marking — adjacent to JALEX's regulatory consulting, with broader geographic reach and an established brand in the same OEM buyer base.
• TÜV SÜD America: International notified body providing ISO 13485 audits, CE Marking, and medical device testing — competes with JALEX on regulatory pathway and QMS work for clients pursuing European and North American market entry in parallel.
• DEKRA Certification: Global testing, inspection, and certification organization with a medical device practice that overlaps JALEX's quality systems and regulatory submission services for OEMs pursuing international market access.
• UL Solutions (Underwriters Laboratories): Global safety science company offering medical device testing, certification, and regulatory advisory — comparable buyer base (medical device OEMs seeking FDA/UL compliance) and overlapping QMS and submission services.
• MasterControl: Enterprise QMS and quality management software provider serving regulated manufacturers including medical device companies — overlaps with JALEX's QMS consulting where customers seek a software-plus-services alternative.

Emerging players

• Greenlight Guru: Medical-device-specific QMS and design-control SaaS platform targeting the same startup and mid-OEM buyer base as JALEX — represents the software-enabled substitute that increasingly automates portions of JALEX's billable consulting work.
• Rimsys: Regulatory information management (RIM) platform for medical device and diagnostics companies — comparable buyer (regulatory affairs teams at mid-size OEMs) and an emerging software alternative to portions of JALEX's submission-preparation service.
• ComplianceQuest: Cloud QMS and EQMS platform with a medical device vertical — competes with JALEX for the QMS portion of an OEM's quality system budget and represents the same automation threat to billable consulting hours.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/JalexMedical
• LinkedInlinkedin.com/company/jalex-medical
• Xx.com/JALEXMedical

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 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 Jalex Medical