FDA, FDA, FDA…..three letter words that may raise unjustified anxiety.

Since 1995, we have worked extensively with many types of medical devices that received FDA scrutiny and approval (interventional cardiology, gastric implantable devices, dermal fillers, long term implantable products for aesthetic surgery, drug combination devices).

If your organization is ISO certified and interested in entering the US market, we can:

• Help you review and transform your quality system to become compliant with cGMPs.
  
  
• Perform mock FDA audit to prepare your organization and staff.
  
  
• Assist you in developing a regulatory strategy and corresponding key milestones.
• We will identify upfront possible risks and develop contingencies.
  
  
• Assist you in your regulatory submissions: 510K, IDE, PMA.
  
  
• Provide training specific to US regulatory requirements.