maytal

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