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Melissa B.
Director Of Quality And Regulatory at Boulder Iq And Boulder Sterilization
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Work Experience
Director Of Quality And Regulatory
Feb 2024 - Present · 11 months
Director At Azzur Group
Jul 2020 - Jan 2024 · 3 years and 6 months
Vp Of Operations
Dec 2019 - Jul 2020 · 7 months
Company Details
Boulder iQ 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 and contract ethylene oxide and chlorine dioxide sterilization, 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. Boulder Sterilization is a division of Boulder iQ providing contract CD and EO sterilization including full-service quick turnaround validations, single lot releases and production runs. We provide: • Product Design and Development • Regulatory and Quality • Manufacturing • Packaging • CD and EO Sterilization 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://boulderiq.com/ https://bouldersterilization.com/
Year Founded
2009
Social Media
Linkedin
Industry
Medical Device
HQ Location
5421 Western Ave Boulder, Colorado 80301, US
Keywords
Medical Device DesigHigh Tech Device DesigFDA 510(k) Regulatory PathwayCE Mark CertificatioClinical Evaluation ReportsISO 13485:2016 CertifieCAPA ConsultingRegulatory AuditHuman Factors DesigPrototype Productio
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