CERICON - Quality System and Regulatory Compliance Professionals

Mission

CERICON is a consulting company that specializes in building strong Quality and Regulatory Systems in FDA-regulated industries with a focus on medical devices. 

We fulfill our mission through:

  • Systems Solutions - We believe in an organizational and systems approach to developing, building, and sustaining strong Quality and Regulatory Systems.
  • Leadership and Teamwork - We work with you to solve problems and develop innovative, robust solutions.  We partner with your key personnel to GET RESULTS!  We develop your staff to continue the work.
  • Knowledge - We have the business, management, quality system and regulatory knowledge to help you solve problems and develop lasting solutions.
  • Integrity - We are committed to conducting our business with strong commitment and high integrity.

The CERICON network is staffed by professionals who have "done the work". Our hands-on knowledge and experience covers a broad range of business, management, Quality System and regulatory issues/situations. 

Services

Although we are not currently accepting new projects, our typical services include the following.

  • Resolution of FDA issues and enforcement actions including FDA Form 483s, Warning Letters and Consent Decrees.
  • Quality Systems remediation and development including system design, gap assessments, training and audits (Quality System Regulation (QSR), cGMP, ISO 13485, MDD, AIMD, CE Marking and other national and international standards)
  • Regulatory compliance to FDA Title 21 regulations including Quality System Regulation (QSR), Registration, Listings, recalls, Corrections and Removals, crisis management, adverse event reporting (MDR), and submissions.
  • Management and Business Process Improvement including financial health, defect elimination, continuous improvement, strategic management and teamwork development.
  • Contract Management to temporarily fill key roles in your Quality Assurance or Regulatory organizations.