Our Philosophy

Our approach to regulatory compliance goes beyond just determining specific problem areas and correcting them.  Regulatory compliance is a perpetual process and can only be effectively achieved and maintained with proper policies in place and staff involvement. Our commitment to our clients is continuous quality system improvement through the development of organizational tools, procedures, and training. Our goal is to provide valuable assistance for meeting regulatory requirements while at the same time developing a quality system that will be a significant long term investment for the company. In addition to meeting regulatory requirements, an effective, well organized quality system saves time and money, and improves customer satisfaction.

We can provide a wide range of cost effective products and services to help meet the requirements of regulatory agencies and enhance your quality system.

• New! FDA Document Collection for Medical Device regulatory compliance.
• Quality System evaluation and gap analysis
• Quality System design or upgrade
• Development of compliant standard operating procedures
• Development of documentation systems and software to assist compliance activities
  • Customer input
  • Design controls
  • Acceptance records
  • Continuous improvement
  • Device and component tracking
  • Corrective / Preventive actions CAPA Facilitator™
  • Management review
  • Training records
  • Calibration control
  • Complaint handling
  • Adverse event handling
  • Audits
• Regulatory and Quality Assurance training
  View CAPA Training Presentation (click link below to download a free copy of the presentation)
• Regulatory action responses
• Mock FDA inspection and ISO audits
• Internal Quality Audits
• Vendor audits