Medical Device Regulatory Services

Getting marketing clearance for your medical device can be a great challenge, especially without the assistance of an established expert. Having to coordinate with myriad regulatory agencies—each with its own requirements, regulations, and guidance—can make approval a lengthy process.

Working with a team that has traveled this road before can significantly improve your chances of success. That’s why Busse Hospital Disposables offers medical device companies the following services to expedite the regulatory process:

US Regulatory Services

  • Pre-market notification — 510(k)
  • Combination product (drug/device) submissions
  • Establishment registration and device listing
  • US Agent

Canadian Regulatory Services

  • Medical device license applications (Class II and III)
  • Combination product (drug/ device) submissions
  • Medical Device Establishment Licenses

EU Regulatory Services

  • Technical File
  • Clinical Evaluations
  • CE Mark facilitation
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