When your organization isn’t yet far enough along to support internal staffing of some leadership roles, we provide your team with top-tier quality and regulatory leadership on demand. Our fractional experts bring strategic oversight and deep industry expertise, driving compliance and growth without the full-time commitment.

 

With our focus on early-stage, small, and medium-sized medical technology companies, we understand that resources aren’t unlimited, but quality and regulatory leadership and management are critical to success even when full-time staffing isn’t yet feasible. We can provide every company, regardless of size or maturity, with top-notch resources in these areas. Our experts can serve as part-time (fractional) heads of quality and regulatory, specialists or engineers within those disciplines, or other roles requiring specific competencies such as the EU MDR requirement for Persons Responsible for Regulatory Compliance (PRRC). We can also be the U.S. Agent for foreign manufacturers.