Quality System Optimization

Quality is not a cost center. It is an investment.


With the recent surge in Food and Drug Administration (FDA) enforcement efforts, the cost of non-compliance has become increasingly significant (i.e. increased FDA scrutiny, financial penalties, lawsuits, loss of brand integrity, etc.). Historically, the money spent on reactively addressing FDA non-compliances, and addressing quality deficiencies, has far outweighed the upfront investment of being proactive and maintaining sustainable quality practices.

This is why companies who have realized that quality is not a “cost center”, but rather an investment, have been able to stay competitive in the marketplace and maintain high levels of product quality and brand equity. These companies invest in quality, seek to continuously improve their business processes, and develop sound strategies for sustainable compliance.

QualityHub can help you regardless of what stage you are in within the business lifecycle (i.e. start-up, growth, or maturity) with medical device product design, risk mitigation activities, Quality System development/improvement, global harmonization/integration/standardization, performance optimization, and preventative contingency strategies.




Quality System Process Improvement & Optimization

  • Conduct process assessments/studies to identify optimization opportunities
  • Identify necessary skills, roles, technology, and procedures to create effective processes that support both organizational growth and development
  • Employ global harmonized standards and processes across the organization that are scalable with your business goals
  • Incorporate applicable regulatory requirements into processes






Mergers & Acquisitions Quality System Harmonization

With increased globalization, acquisitions, and escalating regulatory oversight, companies are facing ever-increasing challenges to achieve operational efficiency and overall compliance as they expand to capture market share. Medical Device and Pharmaceutical companies are especially vulnerable to these risks, given the nature of their products and the intense regulatory burdens under which they operate (i.e. governmental regulatory agencies, notified bodies, etc.). Failure to meet government and industry regulations can result in negative consequences — namely, audits/inspections, fines, seizures, warnings, and injunctions/lawsuits — that adversely affect a company’s productivity, brand integrity, and ability to conduct business.





 Risk Mitigation Strategy

  • Conduct proactive audits/risk assessments to evaluate compliance and regulatory risks
  • Development of continuous improvement and sustainability strategies
  • Assist with the preparation and management of FDA and Regulatory body inspections, including product pre-approval inspections
  • and more…



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