With Product Development, Quality Assurance, Regulatory Affairs, and Contract Manufacturing services all under one roof, ERI Group can integrate into your business to help co-develop innovative new ideas in the medical industry.
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.
Work
World-class capabilities
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
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.
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.
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