AmeXio is an authorized Componize Partner. We bring deep experience in structured content management for regulated industries such as medical devices. Our teams combine compliance knowledge, documentation expertise, and technical implementation skills to deliver reliable, scalable solutions.
We understand the unique documentation challenges faced by medical device companies.
By using Componize, AmeXio helps medical device manufacturers reduce costs, accelerate product release, and meet compliance requirements for ISO 13485, FDA 21 CFR Part 820, and MDR or IVDR standards.
AmeXio’s project methodology is built around accuracy, governance, and user adoption. We support clients from strategy through delivery, ensuring every implementation aligns with business and regulatory goals.
| Phase | Activities | Value Delivered |
| Consultation and Assessment | Requirements gathering, gap analysis, governance planning. | A roadmap designed for your documentation ecosystem. |
| Design and Modeling | Data model, taxonomy, DITA templates, and simplified authoring. | A strong content structure aligned with your business needs. |
| Integration and Migration | Import of legacy data and connection to source systems such as PLM, ERP, or CMS. | A smooth transition with minimal disruption. |
| Training and Adoption | User workshops, developer training, and governance guidance. | Fast user adoption and reduced learning curve. |
| Support and Evolution | Managed services, maintenance, and optimization. | Long-term value and continuous improvement. |
AmeXio’s experience with structured content systems like Componize allows seamless integration between authoring, management, and delivery.
Challenge. A medium-sized medical device manufacturer managed documentation in Word and InDesign, causing versioning issues and slow validation.
Solution. AmeXio implemented Componize with a modular content model, migrated legacy documents, and trained authors.
Results. he client achieved a 40 percent reduction in authoring time, a 25 percent reduction in translation costs, and improved audit readiness through automated traceability.
Integration and Governance
AmeXio ensures that Componize integrates seamlessly with PLM, ERP, CMS, and translation systems. We define governance models, user roles, and publishing workflows to ensure compliance and control. Our scalable architecture supports organizations from single product lines to global portfolios.
Why AmeXio and Componize
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