Global Regulatory Strategies for Medical Technologies


In supporting the development of skills to deliver state of the art medical technologies, it is imperative that regulatory obligations are understood and applied.  The global legal framework to develop and commercialize medical devices is extremely complex and highly regulated.  The ability to interpret and implement these expectations in the innovation process is critical to success.  Key regulatory principles are a priority for inclusion at design and development stage and when incorporated competently and accurately will ensure the positive delivery of safe and effective technologies for human use. 


Learning Outcomes

  1. Compare and contrast the global regulatory requirements pertinent to commercialising high risk medical technologies.   

  2. Explain the technical documentation and post market deliverables to continuously demonstrate safety and efficacy for medical technologies

  3. Evaluate the regulatory and business risks at each stage of the innovation and design process.

  4. Communicate and proceduralize the systematic regulatory deliverables and associated technical file inputs.

  5. Demonstrate the ability to lead a project to approval stage by anticipating and engaging with regulatory experts and sourcing regulatory intelligence.

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