Medical Devices Israel training courses

This two day course has been designed to provide an in depth understanding of ISO 13485:2016. Learn how to apply your knowledge to the development of a ISO 13485:2016 compliant quality management system and help maintain on going certification of their organization.

This two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016.

Optimize your auditing skillswith the internationally recognized ISO I3485:2016 andboost your internal audit capabilities. Gain confidencein planning and performing an effective audit, as well asreporting and taking corrective action where necessary.

Participants will gain the knowledge and skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.

Our one day training course has been designed to introduce medical device manufacturers and other economic operators in the supply chain to the key changes to requirements for CE marking following the publication of the new Medical Devices Regulation (MDR).

Our one day training course has been designed to introduce IVD manufacturers and other Economic Operators in the supply chain to the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR).

Learn about the key requirements, concepts, and the overall process for CE marking under the Medical Devices Regulation (MDR). The CE mark gives access to a market with 500+ million people.

Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five year transition period. To CE mark an IVD in Europe it will soon be mandatory to conform to this Regulation. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors and EU Representatives.

This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market.

Explore the role of risk management during product development and in post market follow up. Develop an understanding of the interface and interaction with Notified Bodies, economic operators (importers, distributors, EU Representatives) and subcontractors/suppliers, according to their obligations under the IVDR.

This course is designed to provide you with knowledge of how the Medical Device Regulation (MDR (EU 2017/745)), standards and guidance documents impact medical device software; software as a medical device; and medical devices with software.

The course is designed to provide you with an understanding of the clinical evaluation process including details on the regulatory requirements, the principles of clinical evaluation, how they are performed and documented.

This course is designed to provide you with an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing and lifecycle of medical devices.  It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard and the MDR 2017/745.

This one-day intensive course enables greater understanding of the key requirements for manufacturing process validation for medical devices. The aim of the course is to enable manufacturers to know what process validation evidence is necessary to demonstrate the manufacturing process is validated.

This intensive one day course will enable a greater understanding of performance evaluation for In Vitro Diagnostic devices under the IVD Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for clinical evidence.

This one-day intensive course enables manufacturers to learn about the key requirements, concepts and the overall process for post-market surveillance and vigilance under the MDR and IVDR.

This one-day intensive course enables greater understanding of the key requirements for technical documentation for medical devices, in line with the European Medical Device Regulation (MDR) requirements in Europe.

This one-day intensive course enables greater understanding of the key requirements for technical documentation for IVDs, in line with the European IVD Regulation (IVDR) requirements in Europe.

This course will prepare you to host a MDSAP audit and allow you to determine if your own internal QMS processes are consistent with the requirements of the MDSAP audit mode for the jurisdictions where your products are marketed.