Equipment Servicing in Minnesota

Innovize is a contract manufacturer specializing in precision die and laser cutting, laminating, printing, and slitting of flexible film-based materials for medical device and personal care applications. The company transforms film-based components into advanced finished products or component parts, seamlessly integrating flexible materials with client electronics and chemistry. Core capabilities include precision die and laser cutting, laminating, printing, slitting, assembly, kitting, and final packaging services. Operations are enhanced through automation and robotics for scalable, efficient production. Innovize holds ISO 13485:2016 certification, demonstrating compliance with medical device quality management standards. The company serves the medical device industry as a dedicated contract manufacturing partner, offering full-scale production or extension of existing manufacturing capabilities. Clients can leverage Innovize's material science expertise and partnerships with materials manufacturers for optimal material selection across diverse medical applications.

Lifecore Biomedical is a US-based contract development and manufacturing organization (CDMO) headquartered in Chaska, Minnesota, with 60 years of operational history in pharmaceutical and medical device manufacturing. The company provides end-to-end CDMO services including formulation and process development, fill-finish operations, analytical testing, stability testing, and assembly and packaging for drugs, biologics, medical devices, and combination products. Lifecore manufactures and supplies premium sodium hyaluronate products used as active pharmaceutical ingredients (APIs) and excipients in both research and GMP-regulated manufacturing environments. The company operates under an Annex 1-compliant quality management system with a 40+ year global regulatory track record and maintains certifications supporting FDA and international regulatory requirements. Lifecore supports phase-appropriate manufacturing from pre-clinical through commercial production, enabling clients to protect resources while maintaining compliance. The facility has demonstrated operational excellence, including zero batch rejections over 1.5 years and manufacturing of 11.5 million vials, with recognition from regulatory inspectors for audit performance. The company serves global pharmaceutical and biotech clients ranging from startups to established pharma companies.

Crest Healthcare Supply is a healthcare equipment distributor serving 45,000+ healthcare locations across the United States. The company operates a 3,000+ square foot warehouse and maintains an inventory of 10,000+ products spanning durable medical equipment, furniture, consumables, and operational supplies. Product lines include nurse call and communication systems (featuring Inovonics pendants and Crest call cords), bed and room products, mobility and transfer solutions (wheelchairs, walkers, crutches), fall prevention and monitoring equipment, aids for daily living, clinical care solutions, lighting systems, personal protective equipment (gloves, masks), infection control products, and operational supplies. The company also offers equipment repair services on a flat-rate basis. Crest Healthcare Supply functions as a one-stop B2B medical supply distributor for hospitals, long-term care facilities, assisted living communities, and other healthcare settings, emphasizing reliable service and product availability.

Kluge Design LLC (KDI) is a precision contract manufacturer specializing in low-volume, complex medical device development and production since 1982. The company designs and manufactures complete medical device systems and mechanical/electro-mechanical subassemblies, with capabilities including CNC machining, custom cable assemblies, laser marking, and design-for-manufacture (DFM) engineering. KDI handles the full manufacturing lifecycle—from product development and prototyping through production, finished goods storage, order fulfillment, and complaint handling/repair services. ISO 13485:2016 certified and FDA-registered, KDI serves OEM partners across cardiology, orthopedics, diagnostic imaging, and other medical sectors, with annual project revenues typically below $1–5M, positioning it as an ideal partner for specialized, lower-volume medical device projects requiring engineering collaboration and rapid completion.

Reflex Medical Corp is a medical device contract manufacturing and development partner serving device manufacturers across product lifecycle stages. The company provides comprehensive in-house capabilities spanning product design, engineering, research and development, rapid prototyping, small-batch to high-volume production, secondary operations, and finishing services. Operating under a single-roof integration model, Reflex Medical enables manufacturers to optimize throughput, explore product differentiation opportunities, and maximize manufacturing investments. The company also serves as a wholesale distributor and authorized service provider for GAKO Unguators, EMP jars, and accessories in North America, offering repair and maintenance services for these specialized devices. Reflex Medical previously manufactured and distributed UnoDose™, a pharmaceutical dispensing device, though this product line was acquired by Topi-CLICK in 2025. The organization combines extensive in-house expertise with state-of-the-art facilities and a demonstrated track record in medical device manufacturing. Capabilities include design optimization, process efficiency consulting, prototyping, and full-scale production support for device companies seeking to outsource manufacturing operations or augment existing in-house capabilities.

Midwest Interventional Systems (MIS) is a vertically integrated, FDA-registered medical device contract manufacturer and design partner specializing in catheter systems and minimally invasive device components. The company designs and manufactures custom medical balloons (non-compliant, semi-compliant, and compliant variants) and medical extrusions (single-lumen to complex multilumen tubing) for interventional and endovascular applications. MIS serves 100+ minimally invasive device companies spanning neurovascular, atrial fibrillation, endoscopy, and other specialties. The company operates three core business units: Components (off-the-shelf and custom balloons and extrusions via online design tools), Design Services (concept-to-commercialization catheter engineering with a dedicated Co-Lab for rapid prototyping), and Manufacturing (pilot through full-scale contract manufacturing with in-house capabilities). Key offerings include IQueue (proprietary online extrusion designer for rapid custom ordering), Balloon Designer, Catheter Designer, and an online component store with 24-hour shipping and $50 minimum orders. MIS maintains ISO 14385:2016 certification and FDA registration. The company employs catheter engineers with 10+ decades of combined expertise and follows a proven 5-phase development methodology. Notable clients and testimonials reference work with neurovascular innovators, endoscope manufacturers, atrial fibrillation device companies, Mayo Clinic physician innovators, and leading MedTech firms.

Technical Services for Electronics (TSE), operating as a brand of AMETEK Paragon Medical, is a custom medical device component manufacturer specializing in precision interconnect solutions, cable assemblies, and laser-processed components for leading medical device OEMs. The company provides collaborative engineering and advanced manufacturing capabilities across 40+ years of medical device innovation, serving electrophysiology, neuromodulation, cardiac rhythm management, patient monitoring, vascular, surgical instruments, orthopedic, and structural heart device markets. TSE manufactures components from specialty materials including Nitinol, PEEK, stainless steel, and silicone. Core offerings include custom electrical interconnects, DENSYTY interconnect systems, cable assemblies with smart PCB integration, laser ablation of polymers, fine wire components, catheter manufacturing, Nitinol laser processing, precision tube cutting, laser welding, and laser hole drilling. The company operates as part of AMETEK Inc.'s Paragon Medical division alongside brands Avicenna and Laserage. TSE provides world-class manufacturing with robust quality systems and integrative service models designed to accelerate time-to-market for innovative medical device concepts across multiple clinical specialties.

RevZero, Inc. is a US-based precision medical device contract manufacturer specializing in regulated orthopedic implant manufacturing. Founded in 2007 and headquartered in Chanhassen, Minnesota, the company provides Design for Manufacturability (DFM) guidance, prototype development, and precision production services for medical device engineering teams. RevZero is ISO 13485:2016 certified and FDA-registered, supporting the full product development cycle from early design through production scale-up. The company manufactures complex orthopedic components including plates, screws, spacers, and assemblies for trauma and extremities applications; spinal devices such as interbody spacers, pedicle screws, rods, and fusion systems; and minimally invasive device components. Manufacturing capabilities include multi-axis CNC machining, Swiss turning, wire EDM, precision finishing, and laser marking. The company works with medical-grade materials including titanium, cobalt-chrome, stainless steels, and PEEK. RevZero emphasizes early manufacturing input to prevent late-stage revisions, predictable timelines, full inspection and traceability documentation, and direct engineer-to-engineer communication. The company positions itself as a partner that reduces revision cycles, improves design manufacturability, and delivers parts ready for real-world clinical use.

Nortech Systems, Inc. is a full-service electronics manufacturing services (EMS) provider established in 1990, specializing in designing and manufacturing complex electromechanical and interconnect solutions for medical devices, aerospace & defense, industrial, and IIoT markets. FDA-registered with ISO 13485 (medical devices) and ISO 9001 certifications, Nortech operates clean room facilities across the United States, Mexico, and China. Core competencies include high-density PCB assembly, flexible and rigid-flex circuits, custom cable and harness assemblies, fiber optic solutions, box-build assemblies, and full system integration. The company provides end-to-end lifecycle management services from concept design through post-market support, emphasizing design for manufacturability, regulatory compliance, and supply chain optimization for mission-critical applications.

Voltas Medical LLC is a vertically integrated medical device development and manufacturing partner headquartered in Cottage Grove, Minnesota. The company provides accelerated, end-to-end services for medical device commercialization under a single project manager, budget, and timeline. Core capabilities span R&D and rapid weekly prototyping (using Arduino, Raspberry Pi, sensors, LCD screens), regulatory services (510k submissions, PreSub/513g work), contract manufacturing (plastic injection molding, micro-molding, die-mold tooling), specialized processes (balloon development, hydrophilic/hydrophobic coatings, UV laser etching, RF and ultrasonic welding), in-house ETO sterilization with validation, packaging and blister tray development, and post-launch support including distribution, warehousing, medical sales, and marketing. The company targets Class I and Class II medical devices and claims capability to bring products to market in under 2 years for under $1 million. Device specialties include ablation catheters, stent delivery systems, diagnostic imaging, laparoscopic instruments, bone plates, endovascular grafts, neurostimulation devices, and vascular catheters.

Nextern Innovation is a vertically integrated medical device contract design, development, and manufacturing organization (CDMO). The company collaborates with innovators and clinicians to design, develop, optimize, and manufacture medical devices across multiple therapeutic areas. Nextern operates four global manufacturing facilities totaling 250,000 square feet, including 20,000 square feet of cleanroom space, with a team of 600+ members worldwide. The company specializes in minimally invasive devices, single-use catheter and metal assemblies, Class III active implantable leads and delivery systems, power systems (catheter and generator development), bioelectronics, and connected care solutions. Nextern Liink, a subsidiary, develops custom, secure, and scalable software solutions for medical device connectivity. Core capabilities include device design and development (bio-simulation, pre-clinical testing, IP support), full-spectrum manufacturing with phased transition from development to commercialization, supply chain management, and life-cycle services including warranty and continuous improvement. The company operates virtual quality management systems and maintains presence in strategically located global manufacturing locations with localized supply chains. Nextern serves cardiology, neuromodulation, and other specialty device markets, with demonstrated expertise in brain-computer interfaces and platforms for labeling and graphical user interfaces.

Sterilmed, Inc., a Johnson & Johnson MedTech company, is a leading provider of medical device reprocessing services. The company specializes in the reprocessing of single-use medical devices through a comprehensive workflow that includes decontamination, cleaning, sterilization, refurbishment, and functional testing—all performed in compliance with FDA guidelines. Sterilmed reprocesses devices originally manufactured by Johnson & Johnson MedTech Companies as well as devices from other original equipment manufacturers, providing healthcare systems with cost-effective and environmentally sustainable alternatives to purchasing new single-use devices. The company's BluFlex initiative offers flexible reprocessing solutions tailored to individual facility needs. Sterilmed supports healthcare providers with device collection programs, staff training, inventory management, and ongoing clinical education to maximize program adoption and sustainability outcomes. Services are designed to help hospitals reduce medical waste, lower procurement costs, and achieve environmental sustainability goals while maintaining or exceeding original manufacturer functional and safety requirements.

Precera Medical is a contract development and manufacturing organization (CDMO) serving medical device original equipment manufacturers (OEMs). The company specializes in precision manufacturing and engineering solutions for complex medical devices, with particular focus on surgical robotics, minimally invasive surgical systems, endoscopy, spine, motion preservation, and neurostimulation applications. Precera delivers end-to-end capabilities spanning design and process development, rapid prototyping, automation-enabled manufacturing, precision machining (multi-axis and Swiss turning), electrochemical machining, implant and instrument forging, secondary processing, and final assembly. The company emphasizes seamless scaling from prototype to production without risky technology transfers, maintaining quality assurance and regulatory compliance throughout the manufacturing lifecycle. Precera positions itself as a true extension of customer engineering teams, offering robust quality systems, preventive maintenance, new product introduction (NPI) support, and risk management practices. The company serves top-tier MedTech OEMs and is oriented toward supporting advanced, precision-critical device development with validation embedded from inception. No specific FDA, ISO, or CE certifications are explicitly stated on the website, though the quality and compliance messaging suggests regulated manufacturing operations.

NACS, Inc. (now Ascential Medical & Life Sciences) is a contract manufacturing and automation solutions provider specializing in mission-critical medical devices, drug-delivery systems, and diagnostic equipment. Founded in 1991 and headquartered in Ham Lake, Minnesota, NACS delivers end-to-end production services including design for manufacturability, prototype development, custom machine building, complete automation design, validation (IQ/OQ/PQ), and turnkey production delivery. The company serves blue-chip manufacturers including 3M, Abbott, and Medtronic, emphasizing scalable, validated solutions that minimize lifecycle costs while accelerating time-to-market. NACS integrates expertise in automated manufacturing technologies, lean principles, and medical compliance to ensure world-class production quality where failure is not an option. The company also manufactures the PurePouch packaging system and related electronic fulfillment solutions for medical product distribution.