USA Regulatory Market access strategy

Maytal experience in the Medical devices and IVD field as also in the US market, allow us to support medical device manufacturer in the definition of a global regulatory and reimbursement strategy for the USA market.
Based on the needs of the company Maytal can supply:
  • General background on the FDA regulations and applicability to the company devices that could to be potentially sold on the US market
  • Background on the reimbursement rules and Identification of the proper CPT codes for the company devices that could to be potentially sold on the US market
  • Device classification determination for the company devices that could to be potentially sold on the US market
  • Medical device registration
  • Labelling requirements analysis
  • US Agent Representation for foreign manufacturers