Product Design & Development
- Product definition
- Feasibility studies
- Product design
- Verification and validation
- Intellectual property arising directly from our work belongs to our partners
Services
Integrated by design
We built ERI Group intentionally to be multidisciplinary and inclusive
We built ERI Group intentionally to be multidisciplinary and inclusive, and we can provide you with anything and everything you need to bring life changing products to market. We see the whole picture, and as a result, our partnerships succeed where others may have failed. We can function both as an outsourced innovation unit that wraps around early-stage companies to get them to market, while also working directly with multinational corporations in need of specialized assistance. Whatever challenge you put in front of us, we’ll figure it out with you, together as a team.
Product Design & Development
Key Services
Contract Manufacturing
- Late stage product development
- Design verification and validation
- Clinical investigations
- Commercial production
- Low-to-moderate volume
- Domestic US based manufacturing support
- Support for transition to high volume manufacturing
Regulatory Affairs
- Regulatory strategy development
- Commercial launches in the U.S. (FDA), Europe (CE mark), Canada, Asia- Pacific and other global markets
- Deep experience in all device classifications, risk levels, and system complexities
Quality Assurance
- Build, improve and maintain compliance for your company’s quality system
- ISO 13485-certified
- Part of the FDA-registered Boulder BioMed family of companies
Learn more about our innovative collaborations in our work portfolio
We built ERI Group intentionally to be multidisciplinary and inclusive, and we can provide you with anything and everything you need to bring life changing products to market. We see the whole picture, and as a result, our partnerships succeed where others may have failed. We can function both as an outsourced innovation unit that wraps around early-stage companies to get them to market, while also working directly with multinational corporations in need of specialized assistance. Whatever challenge you put in front of us, we’ll figure it out with you, together as a team.