No matter where you are in the development lifecycle, we have in-house contract manufacturing capabilities to support you at every stage. Our manufacturing team has decades of experience with advanced electromechanical products, sterile disposables, and software-based products, and because we’re fully integrated across our multidisciplinary team, we can collaborate directly with our development, quality and regulatory teams to ensure the highest levels of quality in the finished manufacturing product.
Simplifying your most complex manufacturing projects
- Low to medium volume manufacturing of electromechanical and disposable products
- Quality management system in compliance with: 21 CFR Part 820, ISO 13485, and ISO 9001
- ISO Class 8 certified clean room, open manufacturing space for non-sterile product
- Preproduction, product launch, manufacturing scale-up, ongoing production, service and spares support
- Design, build, and validate custom test fixtures and test methods
- Sustaining engineering and obsolescence mitigation
Related Case Study
ERI Group collaborated with Advanced CPR Solutions® (ACS) to confirm EleGARD as a patient positioner, and therefore, a Class 1 medical device.