ERI Group offers our clients a world-class, multidisciplinary team that spans the entire process of bringing a medical innovation to market—from product design, development, quality assurance, regulatory compliance, and contract manufacturing. With 35 years of experience and deep technical expertise to handle the most complex projects, we connect the dots so our clients don’t have to.
Our Values
Vision
Building a world-class team, delivering quality services as your trusted partner
MISSION
Our expertise empowering your vision for life-changing products
VALUES
- Honesty & Integrity
- Continuously Learning and Improving
- Innovation
- Fairness
- Respect
- Accountability
Capabilities
An integrated approach to innovation
Providing you with an end-to-end solution
We begin our work with partners at any stage of their development timeline. Whether you engage ERI Group at product development, or during the quality and regulatory stages, or even if you’re ready to engage during the manufacturing stage, our team is ready to help expedite the process.
Entry Point
IP, Development
Planning and Strategy
Planning and Strategy
Entry Point
Prototyping and
risk reduction
risk reduction
Entry Point
Product
development
development
Formal
testing
testing
Entry Point
Global submissions
and market access
and market access
Entry Point
Process development/design
for manufacturing
for manufacturing
Entry Point
New product
introduction
introduction
Stable
Manufacturing
Manufacturing
Consistent project management
and communications
and communications
Entry Point
Quality and compliance to
US and global requirements
US and global requirements
Careers
Life at ERI Group
Being on the frontline of medical innovation inspires us at ERI Group. Perhaps more than anything else, we are a group of talented problem solvers, and our culture is rooted in continuous improvement and the power of intellectual curiosity. If you’re also driven by the challenge and excitement of finding unique solutions to complex problems, we’d love to meet you and talk about your career aspirations.
Team
Our Leadership Team
John has established himself as a leader in the overall integration and execution of regulatory affairs & quality management systems in the medical device design, development and manufacturing continuum. During his 30 years of experience in the medical device field, he has successfully implemented regulatory approvals for various class devices in both the USA and EU, he has successfully mitigated recall and market withdrawal situations for large and small companies. He has designed and implemented Quality Management Systems (QMS) for all classes of devices, compliant to USA, EU, Canadian and other global regulations. In addition, he has successfully remediated systems and records for companies under rigorous regulatory oversight. John is adept at providing practical solutions in compliance with the FDA Quality System Regulation (QSR), ISO13485:2016, ISO 9001:2015, ISO14971, ISO10993, 60601-1, 62304, ISO 14155, 62366-1, HE-75 and a broad range of other technology, device specific standards and regulatory standards including design controls, process validation and statistical analyses. John is widely recognized for presentations and leadership in his field.
Brett has 20+ years of experience in financial and operational leadership working with Life Science, Professional Service, SaaS, Software, and Manufacturing organizations of varying sizes, from high-growth startups to upper-middle market companies.
Prior to ERI, Brett served as Chief Financial Officer (CFO) for multiple private equity-backed companies and as a CPA with a global accounting firm. His expertise includes growing companies, developing and integrating teams and operating in a fast-paced and dynamic environment. Brett has a proven track record of success in driving business growth and profitability, As CFO, he is responsible for implementing strategic growth strategies and focusing on overall business success at ERI Group.