Harmac Medical Products

Harmac Medical Products is a Buffalo, NY-headquartered global Contract Development and Manufacturing Organization

Harmac Medical Products is a Buffalo, NY-headquartered global Contract Development and Manufacturing Organization (CDMO) specializing in the design, development, and manufacture of single-use medical devices. With more than 45 years of experience, Harmac partners with medical device companies from initial product concept and feasibility through design, tooling, automation, validation, high-volume manufacturing, assembly, packaging, and sterilization.

Harmac provides vertically integrated medical device manufacturing capabilities designed to help customers simplify their supply chains, accelerate commercialization, improve product performance, and scale production. Engineering services include product design and development, Design for Manufacturing (DFM), Design for Assembly (DFA), value engineering, process development, tooling, automation, prototyping, process validation, product validation, and continuous improvement.

Manufacturing capabilities include injection molding, insert molding, two-shot molding, RF welding, ultrasonic welding, induction forming, laser cutting and marking, impulse sealing, solvent bonding, heat sealing, automated and semi-automated assembly, and other specialized processes for single-use medical components and finished devices.

Harmac operates certified ISO 14644-1 Class 8 cleanrooms and controlled white-room manufacturing environments, with infrastructure capable of supporting localized ISO Class 7 environments. These controlled manufacturing capabilities allow Harmac to support demanding medical applications requiring high levels of cleanliness, quality, traceability, and process control.

Harmac manufactures Class I, II, and III medical devices for applications including fluid management, wound care, oncology, ophthalmics, point-of-care and in-vitro diagnostics, respiratory care, extracorporeal applications, cell therapy, and blood purification technologies.

Quality and regulatory compliance are integrated throughout Harmac’s manufacturing operations. Harmac maintains ISO 13485:2016 certification, FDA-registered manufacturing facilities, a 21 CFR Part 11-compliant digital Quality Management System, and manufacturing capabilities supporting Current Good Manufacturing Practices (cGMP), PMA, 510(k), and CE-marked medical devices.

Harmac combines engineering, automation, Lean Six Sigma manufacturing, quality systems, and a global manufacturing footprint to support projects ranging from new medical device development and product launches to established high-volume production programs.

Key Capabilities: Medical device manufacturing, medical device contract manufacturing, CDMO, contract manufacturing, single-use medical devices, disposable medical devices, cleanroom manufacturing, ISO Class 8 cleanroom, ISO Class 7 capability, injection molding, medical injection molding, plastic injection molding, insert molding, two-shot molding, RF welding, ultrasonic welding, laser cutting, laser marking, heat sealing, impulse sealing, solvent bonding, induction forming, medical device assembly, automated assembly, manufacturing automation, tooling, custom tooling, Design for Manufacturing, DFM, Design for Assembly, DFA, product development, process development, prototyping, value engineering, process validation, product validation, medical device packaging, sterilization, Lean Six Sigma, high-volume manufacturing, and medical device engineering.

Certifications & Quality: ISO 13485:2016 | ISO 14644-1 Class 8 Cleanrooms | FDA Registered | 21 CFR Part 820 Compliant | 21 CFR Part 11 Compliant | cGMP Manufacturing | ISO 14001 at applicable facilities

Best Fit: Medical device companies, MedTech manufacturers, OEMs, startups, and established healthcare companies seeking product development, medical injection molding, cleanroom manufacturing, single-use device manufacturing, automated assembly, tooling and automation, process validation, packaging and sterilization, value engineering, or a full-service manufacturing partner capable of taking a medical device from concept through high-volume commercial production.