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
Company Details
- Employees
- 5
- Founded
- -
- Address
- Yoqneam, Il
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://www.medtechsme.com
- Keywords
- Medical Device, MDR, Clinical studies, Regulation, IVDR, Strategical solutions, Regulatory and clinical strategy pathway, FDA, PMS, PMCF, Clinical evaluation, Risk Management, Literature Review, Due diligence, Clinical Audit, Peer Review.
- HQ
- yoqneam
Medtech Smes Questions
Medtech Smes's website is http://www.medtechsme.com
Medtech Smes's LinkedIn profile is https://il.linkedin.com/company/medtech-smes
Medtech Smes has
5 employees.
View email and phone details for 5
employees at Medtech Smes.
Medtech Smes's industry is
Business Consulting and Services
Medtech Smes's top competitors are
Pathomation,
Alon Medtech Ventures,
Ceretrieve,
The Medtech Marketing,
Filterlex Medical Ltd.,
Medtech Secrets,
Critecare - Medtech Consultancy,
Bendit Technologies,
Lindexer,
Medimor.
Medtech Smes's categories are Business Consulting and Services
Medtech Smes's founding year is 2020
