Qara Partners is a boutique firm supporting consulting projects ranging from FDA remediation to regulatory submission support. From simple 510(k)s to complex quality management system implementation, Qara’s core mantra of QA + RA – BS means that we customize our lean approach by knowing exactly what regulators are looking for – and what to focus on.
- FDA and EU remediation
- Medical device submissions
- Drug and combination product submissions
- Quality Management Systems (drug and device)
Top 40 Under 40 MedTech Innovator, 35 Under 35 Medtech Professional MN Biz, UofM MDC Innovation Fellow, FDA quality & regulatory expert, industry speaker and online contributor, adjunct professor at St. Cloud State University (QA/RA program).
Prior to joining Qara Partners, David served as CTO of a regulatory consulting company, developing one of the first online consultant marketplaces for the medical device industry. He has 20 years of experience in medicine, design leadership, human interfaces, web app development, strategy, communication, and online education.
Well-versed in operations, HR, finance, management, and communications for small and large companies from the Bay to Minneapolis to NYC. Whether it’s running P&Ls as Financial Controller or keeping everything on track as Chief of Staff, Cleo is a master of professional organization.