Medtech Smes

Medtech SME is a consultancy company which was founded in 2021 by Dr. Danielle Nusimovici-Avadis to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. The focus of Subject Matter Team is to support medical device, in-vitro diagnostic and combination device innovators and companies, finding a practical and reasonable approach to fulfil their legal obligations. MedTech SME can help you make a difference and ensure that patients receive you device, in a timely manner. We provide services such as- Designing the best strategical solution for your company /device in alignment with the regulatory and clinical requirements [#FDA- EU -#MDR ]- Building the best strategy for your Clinical Evaluation Plan to enhance CE MARK per MDR requirements - Regulatory & Clinical strategy & Gap Analysis - Literature Review to support Risk Management, PMS and Clinical evaluation. All literature Reviews are either written or Peer Reviewed by MDs - Clinical research - Risk management - Post market compliance - Due Diligence - Third party audits - Clinical Study Audits #MDR #FDA #Medicaldevice #CRO #Clinicatrails #Clinical #Regualtory #IVDR #literaturereview #SaMD #NB #PSUR #PMCF #PMS #ClinicalBenefit