Boulder BioMed

Development | Regulatory Services | Sterilization | Packaging

Medical Device · Colorado

About

Boulder BioMed is an expert contract consulting firm providing all the services a life sciences company needs to get its product to market. With more than 40 years of experience in regulatory, quality, product development, manufacturing, contract ethylene oxide and chlorine dioxide sterilization, and packaging our single-source solution speeds the product development and regulatory submissions process. Our experts help companies navigate through the process of getting medical device, diagnostic and combination products to the market quickly. The Boulder BioMed family of companies includes: • Boulder iQ: Engineering, design and development services to move products from concept to manufacturing • Boulder Sterilization: Fast, safe, quick-turn ethylene oxide and chlorine dioxide services • Boulder Regulatory and Quality: Comprehensive regulatory affairs and quality assurance services • Boulder BioLabs: On-site distribution and packaging validation, microbiology testing Our team of experts guides companies from product ideation to market launch. We provide the most necessary services for a startup or business to get their product manufactured and generating revenue. Our focus as a team is on high-quality, compliant devices that get the product to the market quickly and efficiently. Visit our websites to let us know how we can help you! https://boulderbiomed.com/

Details

  • Website: https://boulderbiomed.com/
  • Founded: 2009
  • Company Size: 24 employees
  • Headquarters: Boulder, Colorado
  • Specialties: Medical Device Design, High Tech Device Design, FDA 510(k) Regulatory Pathway, CE Mark Certification, Clinical Evaluation Reports, ISO 13485:2016 Certified, CAPA Consulting, Regulatory Audit, Human Factors Design, Prototype Production, Quality Management System Implementation/Maintenance, Regulatory Tech Filing, Ethylene Oxide Sterilization, Contract Sterilization, Medical Device Regulation, Verification and Validation Testing, Contract Manufacturing, Contract Packaging, Plastic Injection Molding, Catheter Design, Chlorine Dioxide Sterilization