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Regulatory and Compliance Services

Traffic LightsAdvances in the medical device industry develop quickly. Companies must focus on how to deliver higher-quality products at a lower cost than the competition while still meeting launch deadlines. Regulatory compliance plays a key role in the quality of medical products and how quickly they are introduced into the market, and many companies want to reduce the effort of compliance while maximizing profit and maintaining or increasing market visibility.

Common Sense Systems offers medical device manufacturers the expertise and creativity necessary to take their products from concept to market. We help you to increase efficiency by continuously working with you to improve your quality management systems.

Regulatory Compliance

  • ISO 13485, FDA GMP and CMDR support
  • FDA 510(k) submissions
  • ISO 14971 risk-management integration
  • European Technical file compilation
  • Handling adverse events such as MDRs and recalls

Quality System Compliance

  • ISO 13485 system design, implementation, and maintenance
  • Implementing and/or maintaining document-control systems
  • Facility assessments for audits and certifications
  • Managing and improving CAPA processes
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Recommendations

"Ten years ago, I brought John Sambrook onto a risky and highly political project that had far-reaching consequences within our company.  As the second member of the team, me being the first, John found solutions to difficult problems, problems I could not have solved without him, averting project failure over and over again.  He produced code and documentation at a professional level I have rarely seen in my thirty years of software engineering.  The project was so successful that the team was spun off as its own company, which now employs more than 700 people."  (Bob Alexander, SonoSite Inc.)

Certified Provider

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We are certified by the Theory of Constraints International Certification Organization.