ISO 13485 Certified Manufacturing Services

Full-service medical device manufacturing with ISO 13485 certification, MDR compliance, and cleanroom production ensuring regulatory traceability and quality assurance.

Quality management services ensuring ISO 13485 and FDA QSR compliance throughout medical device manufacturing. Integrated into comprehensive contract manufacturing solutions.

Contract manufacturing services for medical devices including design, production, and quality assurance. Operates in certified facilities meeting medical device manufacturing standards and regulatory requirements.

EN ISO 13485-certified contract manufacturing of medical devices from prototype to production, supporting both startups and established manufacturers.

Full manufacturing services for diagnostic devices including production control, validation, and quality assurance under ISO13485 standards.

Contract manufacturing and assembly services for medical devices and healthcare products. Facilities are certified by national regulatory authorities and operate under GMP standards.

Scalable manufacturing services for complex medical devices with regulatory compliance and quality assurance. Supports production from prototype to full commercial scale.

Full-service manufacturing solutions for national tenders and private medical device production setups, delivering ISO-certified quality products.

Quality system establishment and management services for medical device manufacturers including ISO 13485 compliance, documentation systems, and regulatory audit support.

Sterilization services for medical disposables and single-use devices, ensuring compliance with ISO13485 and GMP standards.

Full-service manufacturing of sterile medical devices and in vitro diagnostic medical devices. Services include design, tooling, injection molding, sterilization, and assembly.

Contract manufacturing organization services offering agile production capabilities for diagnostic devices and PPE. Supports small-batch and larger production runs with ISO 13485 compliance and SOP-based quality control.