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

Medtech SMEs

Org chart

Teams

Offices