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.
NextWe 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:
Regulatory, design and engineering functions are seamlessly integrated within Cortex, which allows requirements to be considered and implemented at every stage of development. We ensure compliance of our design outputs to be managed within our client’s QMS and market submissions.
Key Cortex Tasks:
Customer satisfaction and patient safety are 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:
Once your product is fully compliant with regulations and meets all requirements, it is ready for market introduction. We provide our clients with compliant outputs you will need for your market submissions, either with a 3rd party partner or with a client’s internal regulatory management.
Key Deliverables:
