About the Summit

The MedTech Regulatory Summit explores topics of urgent practical importance to manufacturers.  From new US and OUS regulatory expectations to cybersecurity, current approaches to product design and evaluation, and emerging trends and technologies, this two-day, triple-track summit offers a rich educational experience together with an opportunity to network and share best practices with your peers.


Topics will include:

  • Med tech business strategy
  • New FDA guidances and initiatives
  • ORA reorganization
  • New European and other OUS regulations
  • Import/Export
  • Compliance and enforcement
  • Inspections, audits, MDSAP
  • Cybersecurity
  • UDI
  • New and emerging technologies
  • Combination products
  • Risk management


Who should attend:

  • Executive management
  • Regulatory
  • Quality
  • Compliance
  • Product developers and stewards 


  • When

  • Wednesday, June 6, 2018 - Friday, June 8, 2018
    12:00 PM - 12:00 PM

  • Where

  • The United States Pharmacopeial Convention
    2601 Twinbrook Pkwy
    Rockville, Maryland 20852
    (800) 227-8772

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