FDA/Regulatory Matters

Rapid advances in medical device, pharmaceutical, food, and related technologies make these industries complex and exciting. The downsides to that are the considerable challenges that companies face, as market entry requirements for each new product must meet rigorous FDA (Food and Drug Administration) and international regulatory standards. As a manufacturer, you want to ensure that your goods are effective and safe for consumer use, but you need to provide quality at the least cost to make your business successful.

Our FDA/CGMP compliance program enables you to get your products to market quickly and to maintain your FDA compliance status. We are an Exemplar Certified Training Provider, bringing over 20 years of knowledge and experience together as your professional consultants. Using our established, practical training techniques, QPS provides the consulting and training that clients need to understand the regulatory requirements and incorporate them into their business. We offer the following courses:

  • Understanding ISO 13485:2016 and FDA QSR (21 CFR Part 820)
  • Current Good Manufacturing Practices (CGMP)
  • Determining Which Requirements Apply to Your Business
  • Rapidly Bringing Product to Market
  • How to Conduct Validation
  • Premarket Notification Submissions 510(k)
  • Quality System Development and Implementation
  • Quality System Audits and Inspections
  • Preparing for FDA Inspections and Compliance Audits
  • Responding to 483’s and Warning Letters
  • Medical Device Reporting and Product Recalls
  • Requirements for Import/Export of Medical Devices
  • Compliance to Food Regulations and Quality Systems

The QPS staff has more than 20 years’ experience in the implementation of quality systems and managing compliance issues. Our experience includes numerous ISO/QS audits and inspections for compliance registration for a wide range of products, services and devices. We know what FDA expects from your quality system and can help you develop a quality system that is simple, practical, and effective in maintaining your quality objectives to comply with FDA requirements. Our FDA Compliance Program provides:

  • Coaching and hands-on guidance to team leaders and team members through successful registration.
  • Structured classroom training in practical, hands-on techniques needed to understand and manage a successful and efficient quality system.
  • Assistance in developing an appropriate implementation plan for your quality system.
  • Enhanced participant skill sets within the organization to drive quality system improvements, remedy urgent problems and deliver effective corrective action.

Whether you need registration for regulatory compliance to sell medical devices or want to implement an ISO system to export your product, you’ll need more teamwork, employee involvement, continuous improvement, and communication than ever.

Our clients are achieving their goals. From strategy to plan, training to implementation, we are committed to delivering success. Contact us today and find out why so many businesses trust QPS.