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EU MDR 745/2017



EU Med Dev Regulation

EU IVDR 746/2017



EU IVD Regulation

FDA Approvals



510k, HDE, PMA, DE NOVO

Clinical Validation

 

Cyber Security and SW Validation

 

Usability and Human Factors

 
Usability Validation

Web Training

 


Med Dev & IVD Global Registration

For manufacturers of In Vitro Medical Devices and Diagnostic Devices that need support to export their products in all the markets of the world, effectively overcoming the maze of regulations and laws in the various markets, which are the real new barriers to entry.


Quality System: Certification & Validation

For all companies, in the medical, cosmetics and other sectors that need support in the implementation and control of their Quality System and its harmonization with the requirements of the new quality system standards: ISO13485, MDSAP, ISO22716, 21CF4820, ISO9001, with a special focus on the organization efficiency elements, to ensure that the quality system is a tool for daily use and not just a formal fulfilment of an obligation.
In the service field, Maytal can provide management and support to companies in all validation activities required by medical and cosmetics companies, such as Process Software Validation, Equipment Validation, GAMP5 Software Validation, Process Validation.


Representative Services

MAYTAL can act as your Regulatory Representative in major medical device markets
  • Europe Authorized Representative (EC REP)
  • US Agent for USA market


Maytal Academy

 

Complex markets with significant regulatory barriers to entry, such as medical devices (MDs), IVDs and cosmetics require adequately prepared resources to easily overcome the obstacles. Allow us to increase the skills of your staff.
MAYTAL is able to provide training courses, in the classroom, at our headquarters or at the customer's premises and also to ad hoc tailor-make training courses designed for professional growth of the client, for all consulting topics (Quality systems, CE marking, FDA registration, MDSAP, New MD regulator, New IVD regulations, etc.).
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