Perfect Pharmaceutical consultants can help you develop Medical Device Technical File for your product for technical submission in various countries or to your clients.
Medical device Manufacturers can also file a “Master file for devices” with US FDA. Normally Medical device manufactures often use another party’s product or facility to manufacture the device. The primary manufacturer needs to submit information related to other party’s product or facility which he is using in his product to gain market approval, in such a case to protect trade secret and to allow FDA evaluation of data, parties whose product or facility is used to manufacture medical device can file a Master file with US FDA and protect its trade secret.
PPC can assist you with
Developing Master file for submission to US FDA
Submitting Master files to US FDA
Preparing technical Master file for client submission
Preparing technical master file for submission in other countries for approval.
