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Denise Lenz
Principal Qa And Regulatory Consultant at Libra Medical
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Work Experience
Principal Qa And Regulatory Consultant
Jan 2014 - Present · 11 years
Lenz Quality Consulting LLC
Owner, Quality Assurance Consultant
Jan 2014 - Present · 11 years
ATS Labs
Director Quality Assurance
Nov 2011 - Dec 2013 · 2 years and 1 months
Company Details
11-50 Employees
Libra Medical, Inc. provides full clinical life cycle contract research organization services and innovative clinical data management solutions to the Regulatory Affairs, Clinical Research, and Quality Assurance functions within life science (Medical Device, Biotech, and Pharmaceutical)companies. Our clients include well-established global medical device companies as well as emerging medical device companies. Clinical Data and Study Management System MAESTRO CTMS/CDMS Easy to use EDC or Paper CRF system available for licensing Completely turnkey and hosted by Libra Medical Clinical: We can assist in designing and running GCP and postmarket Clinical Trials. We have developed protocols, CRFs and run the study from start to finish. Regulatory Experienced in getting approvals in major markets around the world including US (PMA, IDE, 510(k)), EU (Design Dossier, Technical File), Canada, and Australia. Quality Systems Have developed first class quality systems that facilitates creativity and acceleration of time lines rather than slowing the process down. Have gone through multiple audits and inspection with no non-conformities. Specialties Provide an integrated approach to Regulatory, Clinical and Quality so the three departments work together synergistically for faster path to market. Host, design, and manage (turnkey) clinical database for all types of studies.
Year Founded
2007
Social Media
LinkedinFacebook
Industry
Medical Equipment Manufacturing
HQ Location
8401 73rd Ave N, Suite 63 Brooklyn Park, Minnesota 55428, US
Keywords
Contract Research OrganizatioCRORegulatory AffairsClinical ResearchQuality AssuranceClinical Trial Management Software
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