We empower visionaries to change lives.

ERI Group is passionate about transforming your ideas into life-changing medical products. Integrated across product development, quality assurance, regulatory affairs, and contract manufacturing services, ERI Group works directly with your team in a true partnership to deliver revolutionary medical products to the market.

About

Competence
meets confidence.

With more than 35 years of experience and expertise, ERI Group is a world-class, multidisciplinary team that spans the entire process of bringing a medical product to market: Product Development, Quality Assurance, Regulatory Affairs, and Contract Manufacturing. ERI Group connects all the dots across the product development lifecycle so our partners don’t have to. When competence meets confidence, revolutionary innovation is possible.

Engineering.
Regulatory.
Innovation.

ERI Group represents the next chapter in our company’s extensive and proven history.

For the last 35 years, our team has worked directly with our partners on some of the most exciting and complex medical products in the industry, always from our integrated approach. ERI Group aims to better articulate the power of our full-service capabilities, from design and development to regulatory and quality to all types of contract manufacturing. Our new logo pays homage to the brand that brought us here, while also highlighting our three key principles: Engineering, Regulatory and Innovation. Welcome to ERI Group.

Work

World-class capabilities

In our 35 years of operations, we’ve had the privilege of collaborating on hundreds of life-changing medical innovations with our partners. Below is a snapshot of our areas of deep expertise and capabilities, and if there’s a complex idea or challenge you need help with, our experienced team of problem solvers will figure it out.

Capabilities & Expertise:

  • Fluidics and Blood Handling
  • Embedded Software and Controls
  • Advanced Electrical and Electronic Engineering
  • Mechanical Engineering and Design-for-Manufacture
  • Connectivity and Data Cloud Integration
  • Systems Engineering and Usability by Design
  • Integration of Critical Consensus Standards, such as IEC-60601 and ISO-62304 for Streamlined Design Approval and Safety Certifications
  • And more

Services

Product Design & Development

ERI Group collaborates directly with you on all aspects of development, from product definition and feasibility studies to product design and verification/validation. Our team of Mechanical, Electrical, Software and Systems engineers are here to support you. All intellectual property arising directly from our work belongs to our partners.

Quality Assurance

Our quality assurance team works together with product design and manufacturing to ensure the highest levels of quality and compliance and create efficiencies for you and your team. We can assist in building, improving and maintaining compliance for your company’s quality system. Certified to ISO 9001:2015 and ISO 13485:2016, with multiple FDA registrations and successful audits on record.

Regulatory Affairs

ERI Group works with you to develop your regulatory strategy and progress your regulatory approvals, enabling your product to achieve commercial launches in the U.S. (FDA), Europe (CE mark), Canada, and other global markets. Deep experience in all device classifications, risk levels, and system complexities.

Contract Manufacturing

ERI Group supports your manufacturing needs, including late stage product development, design verification and validation, clinical investigations, and commercial production. We support your needs for a low-to-moderate volume domestic US based manufacturing support, and later supporting your transition to high volume manufacturing with ERI Group's global collaborations.

Services

Product Design & Development

ERI Group collaborates directly with you on all aspects of development, from product definition and feasibility studies to product design and verification/validation. Our team of Mechanical, Electrical, Software and Systems engineers are here to support you. All intellectual property arising directly from our work belongs to our partners.

Services

Quality Assurance

Our quality assurance team works together with product design and manufacturing to ensure the highest levels of quality and compliance and create efficiencies for you and your team. We can assist in building, improving and maintaining compliance for your company’s quality system. Certified to ISO 9001:2015 and ISO 13485:2016, with multiple FDA registrations and successful audits on record.

Services

Regulatory Affairs

ERI Group works with you to develop your regulatory strategy and progress your regulatory approvals, enabling your product to achieve commercial launches in the U.S. (FDA), Europe (CE mark), Canada, and other global markets. Deep experience in all device classifications, risk levels, and system complexities.

Services

Contract Manufacturing

ERI Group supports your manufacturing needs, including late stage product development, design verification and validation, clinical investigations, and commercial production. We support your needs for a low-to-moderate volume domestic US based manufacturing support, and later supporting your transition to high volume manufacturing with ERI Group's global collaborations.

Product Design & Development
Quality Assurance
Regulatory Affairs
Contract Manufacturing