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