Arena QMS, the optimum solution for Medical Device Companies
- Arena helps with the effective development and production of medical devices in accordance with the latest legislation and regulations.
- Arena is a unique all-in-one electronic Quality Management Systeem.
- Arena offers an integrated solution for Quality and Product Lifecycle Management.
- Arena guides the user in the preparation and maintenance of the required medical device documentation.
Unify quality and product—all product definitions with
engineering changes and quality processes for a complete DMR— controlled access and traceability with no surprises.
Manage quality processes across all products with all teams using a single product-centric QMS system—people and information connected to build continuous improvement.
Leverage your product-centric QMS to enable collaboration, closed-loop CAPA management, training management, business intelligence, and integrations to meet your quality, market, and cost goals.
Simplify and Maintain Arena Software Validation
Spend less time validating Arena with our complete package of requirements, impact analysis, protocols, execution records, reports, and validation knowledge base experts.
Software applications must be upgraded to meet your expanding business requirements, new technology, and industry demands.
Arena Validation Maintenance Service (VMS):
- Enables you to spend more time on your core competency—and less time validating Arena
- Provides faster compliance for your initial system implementation
- Includes validation services with every future software release
Why Arena QMS?
- Shortened development cycles, lower developments costs and faster market introductions.
- State-of-the-art, meets the latest requirements regarding standards, laws and regulations (FDA, MDR, ISO13485).
- User guidance to meet medical device requirements.
- Helps prepare and collect the right product developments.
- Leading and proven in more than 80 countries, more than 1.300 satisfied customers, of which more than 250 Medical devices companies.
PLM and QMS integrated
Without the complete product and quality record in one system, there is a great chance of issues such as miscommunication, development delays, shipping delays and rework.
Therefore Arena is developed as a combined PLM and QMS, in order to streamline the development of new products (NPD) and the introduction (NPI) of these products and thereby comply with regulatory compliance.
Arena’s eQMS solution supports management of
- Documents and Records
- Bill of Materials
- Training and Training records
- Supply Chain
- Production Records
- Quality and Product Proces Analytics
- Standards and Regulatory Compliance
Implementatie and Quick Start
We offer you a targeted implementation with templates that meet the medical device requirements.
Our support team ensures that your specific implementation needs are met.
Arena is flexible adjustable and Business Ready.
- Implementation at the desired pace
- Predictable Cost of Ownership (TCO)
- Rapid implementation with tangible results
- Easy, automatic updates
- Support form The Netherlands and Belgium (Benelux)