Equipment Servicing in North Carolina

Wheelhouse Medical is a full-service medical device development and contract manufacturing firm specializing in concept-to-commercialization support. The company serves first-time physician-inventors, startups, and established OEMs with comprehensive engineering, design, prototyping, regulatory compliance, and manufacturing services. As an FDA-registered specifications developer and contract manufacturer, Wheelhouse Medical maintains compliance with 21 CFR 820 and underwent FDA inspection in 2024 with zero findings. The firm offers end-to-end capabilities including advanced design technologies, rapid prototyping, operations and fulfillment, quality assurance, supply chain management, and customer support. With over 50,000 engineering hours, 30+ issued patents, and 27 satisfied clients across nearly every continent, the company provides flexible service options ranging from targeted project assistance to complete development and market-launch management. Wheelhouse Medical also offers quality management system integration and builds new QMS platforms from the ground up for clients. The company has been in business for 5 years and positions itself as an approachable, reliable partner adapting to client needs regardless of company size or project complexity.

Haywood Vocational Opportunities, Inc. is a non-profit medical device manufacturer and contract manufacturing organization based in Waynesville, North Carolina. With over 50 years of experience in the healthcare industry, HVO provides custom contract manufacturing, packaging, kitting, and logistics services for medical devices and surgical products. The company operates 100,000 square feet of climate-controlled 3PL warehouse space licensed for medical device storage and inventory management. HVO's core business services include contract cutting, packaging, and kitting for multiple industries; medical packaging and contract manufacturing tailored to healthcare sector requirements; design and development of medical devices and custom surgical drapes; and disposable medical products manufacturing. The company maintains a mature Quality Management System (QMS) aligned with industry standards and is ISO 13485-2016 registered, demonstrating commitment to medical device quality and regulatory compliance. HVO is also CARF accredited (Commission on Accreditation of Rehabilitation Facilities), reflecting excellence in service delivery. Beyond manufacturing, HVO operates as a social enterprise providing vocational training and community engagement programs for individuals with disabilities. Community services include day programs (The Hub, LTCS, ADVP, Innovations), employment training and supported employment services, transitional student services (TSS), pre-employment transition services (Pre-ETS), and long-term follow-along support. The organization serves as a vocational rehabilitation partner in Western North Carolina, supporting workforce development and community integration for individuals with developmental disabilities and disadvantages.

Robling Medical is a contract manufacturing and product development partner specializing in medical device design, validation, regulatory support, and full-scale sterile disposable and electromechanical assembly. The company operates a 75,000 sq. ft. facility with four ISO-certified cleanrooms and 30+ years of medical device and life sciences manufacturing experience. Core service lines include Design for Manufacturing and Assembly (DFMA) with focus on material and process selection, comprehensive validation and verification (V&V) testing including sterilization and biocompatibility protocols, regulatory filing support, sterile disposable manufacturing (bonding, tipping, heat sealing, ultrasonic welding, kitting), form-fill-seal packaging for flexible and rigid medical packaging, and full electromechanical assembly including cable and harness work, PC board flashing, imaging, integration, and functional testing. The company produces millions of sterile packages annually and supports product development from prototype runs through full commercial production. Robling serves mid-sized and large medical device OEMs across diverse therapeutic areas, managing end-to-end manufacturing, quality, and regulatory compliance. The company does not manufacture finished medical devices for end-user sale but rather provides contract manufacturing services to medical device companies.

Lighthouse Lab Services is a Charlotte, North Carolina–based full-service medical laboratory consulting, recruiting, and operational solutions firm. Founded in 2003 and expanded through strategic acquisitions including Elite Diagnostics (2019), the company serves as a comprehensive partner for laboratory startup, compliance, staffing, and operations management. Services include CLIA/COLA/CAP certification and compliance support, laboratory startup and design, specialized recruiting and medical director placement (serving 200+ CLIA-accredited labs nationwide), equipment procurement and instrument servicing with OEM components and FDA-certified engineers, test validation, quality management, revenue cycle management and payer contracting, LIS software solutions (Beacon LIS platform), and specialized molecular and toxicology laboratory solutions. The company specializes in infectious disease, pathology, molecular diagnostics, toxicology, and cytology. With a team of 150+ experts managing and supporting hundreds of laboratories across the United States, Lighthouse positions itself as the nation's largest dedicated medical laboratory consulting and recruiting firm.

Joerns Healthcare is a vertically-integrated designer, developer, and manufacturer of post-acute care equipment and solutions serving long-term care, assisted living, skilled nursing, and homecare settings. The company specializes in fall management, advanced wound care, patient handling and mobility, and integrated care solutions. Core product categories include hospital beds (including low-profile fall-risk reduction models), therapy surfaces (featuring the proprietary Dolphin® Fluid Immersion Simulation® system), patient lift systems, transfer aids, and specialized mobility devices. Joerns operates as a full-service provider with clinical evidence supporting product efficacy: their low-bed design reduces fall risk by 36%, and their fluid immersion therapy system is clinically equivalent to air-fluidized systems per Northwestern University research. The company also offers connected care and health technology solutions including Joerns Connexio®, a chronic care management platform; an asset management system for real-time equipment tracking and optimization; and digital wound imaging technology for bacterial load detection. Services include AssetCare™ asset management programs, training and education for healthcare professionals, and customer support. With over a century of operational history and five decades of innovation leadership, Joerns targets administrators, healthcare facility operators, and individual homecare users. The company emphasizes clinical outcomes, operational efficiency, and financial value through standardized, configurable product portfolios designed to reduce total cost of ownership and support evidence-based care delivery across post-acute settings.

Cathtek is a full-service contract manufacturer specializing in the design, prototyping, and sterile manufacturing of disposable medical devices. The company operates a 16,000-sq. ft. facility in Walkertown, North Carolina, with over 20 years of experience in the disposable medical device industry. Cathtek provides end-to-end services including concept development, regulatory design controls, prototyping, and full-scale sterile product manufacturing. The company serves as a manufacturing partner for medical device innovators seeking to bring products to market with speed and precision. Cathtek maintains FDA Current Good Manufacturing Practices (cGMP) compliance and ISO 13485 certification for the design and manufacturing of sterile medical devices. The company offers comprehensive supply chain management, consolidation services, and distribution capabilities. Cathtek was acquired by Nissha Co., Ltd. in 2021. The firm's expertise encompasses regulatory strategy, design engineering, and scaled production of sterile disposables, positioning it as a contract manufacturing solution for companies across the medical device spectrum.

Atalys is a vertically integrated medical device contract manufacturing platform specializing in extreme precision plastic injection molding, highly engineered tooling design, and mold making for critical surgical and medical device applications. The company provides end-to-end manufacturing services including design for manufacturability (DFM), advanced thermal management and cooling optimization, automated assembly, and zero-defect quality systems. Atalys serves OEM medical device manufacturers across surgical access, fluid delivery, drug delivery, and other precision-dependent markets. The company operates multiple injection molding presses with in-house mold making expertise (500+ years of combined floor experience) and manages complex manufacturing programs with specialized program management and quality assurance. Manufacturing capabilities extend to micron-tolerance components for life-saving surgical technologies. The company also serves consumer, industrial, aerospace, and defense sectors. No specific FDA 510(k) or ISO certifications are explicitly mentioned on the website.