The Use of Standards in the Design and Development of Medical Devices Seminar - Petah Tikva, IL
26.02.2020 — 26.02.2020
genae and MedicSense are excited to invite you to their seminar on Wednesday February, 26 in Petah Tikva, Israel which 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.
- 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
- Language: Hebrew
- Regular fee: 1500 NIS + VAT
- Discounted fee for active clients: 1300 NIS + VAT (defined as active Medicsense/genae clients in the past year)
- Additional information: 052-7277276