Maytal Academy

training We strongly believe that training and competence are the main drivers of company growth, in all economic sectors, and in particular in companies operating in highly regulated markets such as the MD. We believe that training to acquire competence, must be proven through experience and then through the practical verification of the theoretical concepts that we present. The MAYTAL training offers practical and applicable solutions for the company, aimed to promote learning and growth of the resources involved in the training, and proposes practical solutions tested in the field in years of consulting experience, and validated in contacts with main globally Competent Authorities (FDA, HC, ANVISA, etc.) and with several European Notified Bodies. We can offer you several courses taht can be presented in different forms:
  • The approval process for medical devices for the US market and the UDI.
  • Registration of medical devices for Canada
  • FT for the international market: STED, TOC, EU MDR 745/2017
  • The new EU MDR 2017/745 for Medical Devices
  • The new EU MDR 2017/746 for IVDs
  • Risk management: requirements, methods and solutions for compliance with ISO 14971
  • Software validation for medical devices according to IEC 62304
  • Software validation for regulated processes, practical examples of validation of SW ERP and Excel files
  • Standard ISO 13485:2016: news and practical solutions for the application of the requirements
  • MDSAP (Medical Device Single Audit program) for access to the US, CANADIAN, BRAZILIAN, JAPANESE and AUSTRALIAN markets
  • Process validation: Basic concepts (IQ, OQ, PQ), validation protocols and reports and practical examples of the most common processes
  • Etc..

Maytal Academy

Distance learning through web training is today the fastest solution to increase business know-how. The training program includes the connection to a virtual class room where you can follow the course step by step and check your level of learning online.

Educational

MAYTAL is able to plan, together with the client companies, paths for professional growth of company personnel tailored to each company/resource, through a mix of classroom activities and support in the field to transform the theoretical knowledge into practical experience and encourage the growth.

On Site

MAYTAL is able to provide on-site courses, at the customer's premises, for all types of service provided, possibly also in "funded" mode through the accredited training bodies.