Regulatory Consulting for U.S. FDA, Canadian TPD and European MDD Requirements

Preparing and Submitting Regulatory Documents

·         Pre-market notifications [510(k)s]

·         Pre-market approval (PMA) applications

·         Master files

·         Reviewing and Developing Instruction Manuals and Other Labeling for FDA Compliance

·         Providing Liaison with FDA

·         Canadian device license applications as well as CE Marking preparation and application for MDD

·         Product classification and essential requirements determination

·         Preparation for FDA inspections and registrar or Notified Body assessments

·         Assestment study, implementation and follow-up for Biological Evaluation of Medical Devices and Biomaterials according to ISO 10993 standard and regulatory requirements, testing program, preparation of test house planning, test house shopping & selection, most profitable strategical approach for most economical testing program, providing lieson with the research institutes, CROs, governmental bodies

·         Preparation of EMI & EMC testing program for hardware, firmware and for all electronic products, providing test houses and lieson

·         Preperation of projected budget for testing programs

·         Evaluation of test results, conclusions and reports, providing strategical approach to submit specific products test results based on the regulatory requirements to asses the safety for their approbation from governmental bodies

·         Assestment study and follow-up for Biocompatibiliy testing program to provide the safety of specific product

·         Recall strategies

·         Manufacturing and software information for FDA or Canadian submissions