The Use of Standards in the Design and Development of Medical Devices - IATI Member DiscountFeb. 26, 2020
IATI Members will enjoy a NIS200 discount on this seminar.
The seminar will describe the appropriate use of standards for the design and development of medical devices. The seminar provides clarity and explanation about the regulatory framework, policies, and practices regarding the appropriate utilization of standards for regulatory assessment and regulatory requirements fulfillment.
Join Uri Hoffer, Sr. Project Manager at MedicSense, for this must-attend seminar.
- Standards and regulation: different and complementary
- Understanding the link between standards and legislation
- What are the benefits of using standards as a tool for smart/better regulation? How standards can work for you?
- International classification of standards.
- The EU approach: ‘State-of-the-Art’ – Role of standards in the European regulatory system. (MDD, MDR & IVDR).
- FDA approach – Recognized Consensus Standards
- Health Canada – recognition and use of standards under the Medical Device Regulations
- Identifying Standards for Particular Devices
- Proving Equivalence Between Standards
- Tracking New/Revised Standards
- How to save money on Standards Purchasing?
D&D Engineers, QA Associates, RA Associates, Clinical Professionals.
Date: 26 February from 09:00-15:00
Regular fee: 1500 NIS + VAT
Discounted fee for IATI members: 1300 NIS + VAT
Additional information: 052-7277276
Looking forward to welcome you!