Medical Device Manufacturing

Focus on Developing Breakthroughs Instead of Navigating Regulatory Hurdles

Why Medical Device Manufacturers Choose ION

Delivering high-quality products to patients and consumers consistently is paramount in the medical device industry while ensuring customer safety and compliance. Managing supplier quality and cost containment while keeping pace with changing regulations and competitive pressure requires modern, sophisticated technology that is flexible. ION Factory OS provides medical device manufacturers with an operations management platform designed to adhere to the medical device industry's strict quality control standards and data privacy requirements.


  • Regulatory Compliance: Comply with stringent regulatory standards such as FDA's 21 CFR Part 820 (Quality System Regulation) and ISO 13485 (Quality Management System for Medical Devices).

  • Traceability and Serialization: Use ION to track production processes in detail and trace individual components through delivery to the end user to ensure quality, safety, and compliance with regulatory requirements.
  • Validation and Verification: ION supports verification processes required for regulatory compliance, including validation of software and equipment used in manufacturing processes.
  • Change Control Management: Ensure that all alterations to products, processes, equipment, or documentation are methodically managed, tracked and accessible for audits, analysis, and improvement.
  • Data Security and Compliance: Protect sensitive patient information and ensure compliance with data privacy regulations such as HIPAA (Health Insurance Portability and Accountability Act).
  • Supplier Management: Integrate ION with ERP and PLM to ensure the quality and traceability of materials and components sourced from external suppliers, so you can closely contain defects and contaminants.
  • Corrective and Preventive Actions (CAPA): Automate CAPA processes to identify, address, and prevent non-conformities and quality issues, including root cause analysis and implementation of corrective actions.
  • Scalability and Flexibility: Adapt to changing requirements, product variations, and scale production without disrupting timelines. As new technologies are introduced, use ION’s open API to connect systems, robots, and machines for enhanced automation and efficiency.

See How Other Manufacturers Are Gaining Value From ION

Ready to discover what ION Factory OS can do to accelerate your production?