Keys to Regulatory Success

Cortex builds regulatory strategy into the first steps of your product development process. We help you learn your product’s regulatory challenges early, and provide the in-house expertise to overcome those challenges. Then we execute.

Here’s how we we do it.

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Strategy

We introduce regulatory and quality planning at the “Basecamp” stage of developing your product. Researching and understanding regulatory constraints for your product early on reduces the risk of expensive redesign and retooling that may occur later on with insufficient planning.

The Regulatory and Quality Planning Report provides:

  • Knowledge of your product’s place in the market
  • The specific requirements for quality and user/patient safety
  • An overview of predicate products
  • Internal and external testing requirements
  • A suitable “go-to-market” application process
  • A clear understanding of what must be built into your product to be allowed to market
  • A concrete framework that best illustrates the process to potential investors
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Management

Regulatory, Design and Engineering functions are seamlessly integrated within Cortex, which allows requirements to be considered and implemented at every stage of development. We provide regulatory and quality management services from design, to market introduction, to post-market support.

Key Cortex Tasks:

  • Representing your product to Nationally Recognized Testing Labs (NRTLs) and government regulatory bodies (FDA, CE, Health Canada, FCC, IC)
  • Analyzing and mitigating risk in Design and Engineering
  • Developing product labeling, specifications, and other outward published regulatory data (such as intended use and indications for use statements)
  • Ongoing support after commercialization, allowing you to focus on your business instead of annual audits, quality reporting and ongoing compliance management
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Quality

Customer satisfaction and patient safety is driven by adhering to regulatory standards and complying with a quality management system (QMS). A QMS provides processes and accountability by which your company operates, and under which your product is developed, to ensure patient satisfaction and safety. We develop your product under our own certified QMS, and can work with you to create, understand, and use your own QMS as a driving factor of product success.

Key Considerations: 

  • ISO 9001 for customer focus and customer satisfaction quality
  • ISO 13485 for patient focus of medical device development and safety
  • IEC testing management
  • Bench and Clinical testing management
  • Internal Audits and Management Reviews
  • External audits for certification
  • QMS management
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Getting to Market

Once your product is fully compliant with regulations and meets all requirements, it is ready for market introduction. We work with you to submit successful regulatory applications for clearance and licensing of your product into your intended market.

Key Deliverables:

  • Interface with FDA, CE, Health Canada, notified bodies for medical devices
  • Apply for Medical Device License, 510(k) and other market applications
  • Non-medical industry market applications
  • Build and assemble the market submission application
  • Submit the application as your representative
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