INDUSTRY 01/04
High-volume production
with traceability built in
Line integration, OEE and validation for medical device manufacturers running hundreds of machines across multiple sites.
Talk To Us ►
Why Réalta
Medical device manufacturing combines high volumes, high product mix and strict design and process controls. We have integrated, commissioned and validated automated lines across global sites, and connected 200+ legacy and modern machines into one plant-wide view of performance.
The Pressures You Face
Device manufacturers have to scale production and introduce new products quickly, while proving that every process is controlled.
- Islands of automation and legacy machines that do not share data
- New product introductions that need lines integrated and validated quickly
- Multi-site rollouts that need to be consistent site to site
- Traceability requirements across components, processes and finished devices
How We Help
• Line integration and NPI
Integration, commissioning and validation of automated lines, with repeat lines rolled out across sites.
• OEE and asset utilisation
Connecting legacy and modern machines over OPC UA, MTConnect and MQTT for real-time OEE and downtime analysis.
• Traceability and genealogy
Capturing process and production data to support device history records and UDI.
• Process validation and CSV
IQ, OQ and PQ, and GAMP 5 validation of the systems that record quality data.
Regulatory landscape we work within
- FDA 21 CFR Part 820 (Quality Management System Regulation)
- UDI requirements and 21 CFR Part 11
- ISO 13485
- EU MDR 2017/745
- ISO 14971
Our Technologies & Partners
Tursted across regulated manufacturing
works across a broad range of industrial automation platforms and technologies, including:
Insights and Perspectives
Ideas for more connected
manufacturing
Technical insight, practical guidance and real-world thinking from Réalta specialists.
REALTED CASE STUDIES
MEDICAL DEVICES
Introducing a new line or chasing OEE across a site?
Talk to us.
Start The Conversation
Ready to unlock your digital potential?
End-to-end automation, digital transformation and AI solutions for regulated environments.
UNITED STATES
+1 302 509 4401
IRELAND
+353 21 243 9113
GLOBAL CAPACITY
Ireland - Unites States - India