Cretex Medical

Name

Cretex Medical

Legal name

Cretex Medical

Website

https://cretexmedical.com

Company type

Private

Founded year

1924

Operating status

Operating

Headcount range

1,001–5,000 employees

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)

SIC

Surgical & Medical Instruments & Apparatus (3841), Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842)

akta.pro primary industry

Sterilization Services & Contract Reprocessing (ETO/Gamma/E-beam providers) (HLAHANAB)

akta.pro secondary industries

Sterilization Consumables & Packaging (Wraps, Pouches, Indicators, Trays/Containers) (HLAHANAC), Sterile & Aseptic Medical Packaging (Pouches, Wraps, Sterile Barriers) (IMALAIAB), Medical Device Packaging (Trays, Clamshells, Kits) (IMALAIAD)

Keywords

• Medical device manufacturing
• Contract manufacturing services
• Precision machining
• Additive manufacturing
• Sterile packaging sterilization

Headquarters

HQ city

Elk River

HQ country

United States

HQ region

North America

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Supply Chain, Infrastructure, Technology or R&D, Marketing or Sales, Operations

Revenue model

1. Contract Manufacturing Services: Project-based contract manufacturing fees for medical device components and finished devices. Revenue derived from machining, metal fabrication, additive manufacturing, injection molding, stamping, laser processing, assembly, and packaging services. Billing structured around phased project milestones (Project Planning/Design, Validation Readiness, Validation Execution, Design Transfer). Pricing based on project scope, complexity, volumes, and services required.
2. Engineering Services: Fees for engineering and technical services including design support, precision tooling, process validations, and project management. Provided as part of comprehensive product lifecycle support from prototype through production.
3. Pre-validated Solutions: Recurring revenue from pre-validated packaging (QSEAL) and sterilization (QSTERILE) solutions that customers adopt, with ongoing validation support and product-specific testing services.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Cretex Medical is a medical device contract manufacturer providing end-to-end manufacturing and engineering services from prototype through high-volume production. Its capabilities span precision machining, additive manufacturing (Laser Powder Bed Fusion), metal fabrication, injection molding, stamping, laser processing, assembly, sterile packaging, and sterilization management, delivered through operating subsidiaries rms Company, QTS, and CDT for medical device OEMs in therapeutic areas including orthopaedics, spine, vascular, active implants, neuro/cardio stimulation, and ophthalmology. The company also offers proprietary pre-validated QSEAL packaging and QSTERILE EO sterilization solutions that reduce customer development costs and time-to-market.

Product overview

Cretex Medical is a contract manufacturing organization offering end-to-end manufacturing and engineering services for the medical device industry through a platform of three operating companies: RMS (precision machining, additive manufacturing, metal fabrication), QTS (assembly, kitting, packaging, sterilization management), and CDT (injection molding, progressive stamping, laser processing, advanced assembly). The company operates proprietary solutions including QSEAL pre-validated packaging and QSTERILE pre-validated EO sterilization cycle. Their comprehensive capabilities span from prototype through high-volume production, supported by engineering services for design support, tooling, validations, and project management. Cretex Medical serves multiple therapeutic areas including orthopaedics, cardiology, neurology, ophthalmology, and vascular access.

Differentiator

Problem solved

Functional benefit

Brands

• QSEAL: Proprietary pre-validated sterile packaging system for medical devices
• QSTERILE

Products and services

• Manufacturing Services End-to-end medical device contract manufacturing services spanning additive manufacturing, assembly, laser processing, machining, metal fabrication, injection molding, prototyping, secondary processing, stamping, sterile packaging, and sterilization management for medical device OEMs from prototype through high-volume production.
• Engineering Services Engineering and technical services including phased design support, precision tooling, process validations, project management, and prototyping provided across the medical device product lifecycle from prototype through high-volume production.
• Precision Machining Services High-precision machining services including 5-axis milling, Swiss turning up to 13-axis, EDM (wire and Ram), grinding, gun drilling, and ultrafast femtosecond laser micro machining for medical components and implants, leveraging over 900 high-precision machine tools.
• Additive Manufacturing Services Laser Powder-Bed Fusion (LPBF) direct metal printing services for medical implants, instruments, and components, with validated materials including titanium alloys, cobalt chrome, and stainless steel, supported by FDA Master File Reports and ISO/ASTM certifications.
• Metal Fabrication Services Metal fabrication services including laser cutting, stamping, turret punching, press brake forming, CNC machining, and wire forming for cases, trays, enclosures, and chassis used in medical device applications.
• Assembly, Kitting & Packaging Services Medical device assembly, custom kitting, and validated packaging services including finished device assembly, UV-cure bonding, ultrasonic welding, and sterile barrier packaging performed in ISO Class 7 and Class 8 cleanrooms.
• Cleaning & Passivation Services Precision cleaning and passivation services for medical device components performed in ISO Class 8 cleanrooms, using ultrasonic cleaning, automated cleaning line systems, and citric/nitric acid passivation.
• Sterilization Management Services Full suite of medical device sterilization management services including ethylene oxide, gamma, e-beam, x-ray, and steam sterilization coordination, validation, and testing services.
• Label Development & Printing Services Medical device labeling solutions including UDI-compliant barcoding, thermal transfer and inkjet printing, and support for GS1 and HIBCC barcode formats.
• Supply Chain & Materials Management Services Comprehensive supply chain and materials management services including sourcing, inventory optimization, incoming inspection, and supplier management for medical device OEMs.
• Project Management Services Phase-based project management services from quote through validation to production, with dedicated project managers and transparent communication throughout the medical device product lifecycle.
• Engineering, Inspection & Validation Services Comprehensive engineering, inspection, and validation services including IQ/OQ/PQ protocols, package seal validation, cleaning validation, sterilization validation, and contract laboratory testing for medical devices.
• Package Development Services Custom medical device package development services from concept to completion, including design optimization for clinical use and shipping conditions.
• QSEAL Pre-Validated Packaging Proprietary pre-validated sterile packaging system for medical devices offering PETG trays, poly/tyvek pouches, nylon/tyvek pouches, and foil pouches, with 5-year real-time aging validation. Reduces packaging development costs by approximately 30% and development time by up to 50%.
• QSTERILE Pre-Validated EO Sterilization Cycle Proprietary pre-validated ethylene oxide sterilization cycle using a cycle calculation approach with low concentration EO that reduces EO emissions, minimizes cycle times, and accelerates time to market by eliminating customer need for full EO sterilization validation.
• RMS (rms Company) Operating Subsidiary Cretex Medical operating subsidiary delivering precision machining, additive manufacturing, and metal fabrication services for medical device components, implants, and instruments via over 900 high-precision machine tools and 30+ metal AM systems, with EN ISO 13485:2016 and ISO/IEC 17025:2017 accreditations at Coon Rapids, Minnesota.
• QTS (Quality Tech Services) Operating Subsidiary Cretex Medical operating subsidiary offering assembly, kitting, packaging, cleaning, labeling, sterilization management, and supply chain services for medical devices and pharmaceutical industries, with FDA registration, ISO 13485, ISO 11607, MedAccred, and J-PMDA certifications and ISO Class 7 and Class 8 cleanrooms in Bloomington, Minnesota.
• CDT (Component & Device Technologies) Operating Subsidiary Cretex Medical operating subsidiary offering contract manufacturing for precision medical components and assemblies including injection molding, progressive stamping, laser processing, and advanced assembly at its Brooklyn Park, Minnesota facility.

Segments8 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators7 records

Recent moves13 records

Expansion highlights5 records

Direct peers

• Donatelle: Donatelle is a medical device contract manufacturer specializing in precision machining, molding, and assembly for implant and diagnostic applications. Comparable to Cretex's precision machining and assembly capabilities for Class II/III devices.
• Viant Medical: Viant is an end-to-end medical device contract manufacturer offering engineering, precision machining, injection molding, assembly, packaging, and sterilization. Comparable to Cretex for its full lifecycle contract manufacturing plus sterile packaging and sterilization services.
• Tegra Medical: Tegra Medical specializes in precision machining, metal forming, injection molding, and assembly for medical device OEMs. Directly competes with Cretex in precision components and finished devices for surgical and implant applications.
• Orchid Orthopedic Solutions: Orchid is a global orthopaedic contract manufacturer with machining, forging, casting, and finishing capabilities. Closely comparable to Cretex Medical's orthopaedic-focused contract manufacturing for implants and instruments.
• Avalign Technologies: Avalign is a medical device contract manufacturer focused on orthopaedic implants, spinal, and trauma instruments with vertically integrated machining, finishing, and assembly. Directly competes with Cretex's RMS business in orthopaedic contract manufacturing.
• Integer Holdings: Integer Holdings is one of the largest medical device contract manufacturers, offering precision components, finished devices, and leadwires for CRM, neuromodulation, and vascular markets. Directly comparable to Cretex Medical in serving Class III active implant OEMs with machined and assembled components.
• Marle Group: Marle Group is an European-headquartered medical device contract manufacturer with precision machining and assembly capabilities serving orthopaedic, spinal, and trauma markets. Closely comparable to Cretex Medical's RMS business in implant-focused contract manufacturing.
• Medbio: Medbio is a medical device contract manufacturer offering injection molding, assembly, and packaging services. Comparable to Cretex's CDT subsidiary for precision molded and assembled medical device components.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights4 records

Customer concentration

• YouTubeyoutube.com/@cretexmedical3209
• Facebookfacebook.com/CretexMedical
• LinkedInlinkedin.com/company/cretexmedical

Compliance14 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries3 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 Cretex Medical