Medical Device Software development

חדש

Medical Device Software developmentin accordance with MDR/IVDR, IEC 62304 and 82304-1
Software as a Medical Device (SaMD) & Software in a Medical Device (SiMD)

בהדרכת: Mr. Vincent van der Meer

תחומים: אביזרים ומכשור רפואי (אמ"ר), מומחים מחו"ל, רגולציה - תקינה

מק"ט: 241129

גרסה להדפסה

נווט אותי לשם

עמוד הבית הקורסים Medical Device Software development

In healthcare, besides hardware, there is an increasing development and application of integrated software (Medical Device Software or MDSW) and stand-alone Software as a Medical Device (SaMD).

These products are also subject to the regulatory requirements of the MDR and IVDR.

For the development of medical software, among other things, there...המשך קריאה

In healthcare, besides hardware, there is an increasing development and application of integrated software (Medical Device Software or MDSW) and stand-alone Software as a Medical Device (SaMD).

These products are also subject to the regulatory requirements of the MDR and IVDR.

For the development of medical software, among other things, there are international standards that are also applied in Europe. By using these standards during medical software development, a software developer can ensure that the delivered product meets the legal requirements. This includes software development life-cycle principles and cybersecurity. This training covers both theory and practice, enabling you to make a substantial contribution to software development within the medical device field as an expert within your organization.

תאריכים:

02/12/2024
03/12/2024
09/12/2024
10/12/2024

מתעניינים? לחצו כאן

מיקום הקורס: מועבר באמצעות Zoom

משך הפעילות: 2 ימי לימוד. 4 מפגשים, 4 ש"ל כל מפגש

שעות: 17:30 - 14:00

נקודות זכות: 2

שפת הקורס: English

עלות הקורס המלאה: ₪4,600 + מע"מ

מחיר מוזל עד 24 נובמבר, 2024:
3900 ₪ + מע"מ.

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יש לך שאלה? יש לנו את כל התשובות

מה תכני הקורס?

Basic principles of software development MDR: Qualification and classification (MDCG 2019-11) IEC 62304 – process and requirements IEC 82304-1 – process and requirements Link to risk management SOUP / Legacy SW Software release Feedback & change management

Module 1: Regulatory aspects of medical device software
Module 1.1 Introduction to CE marking
Module 1.2 Qualification and classification
Module 1.3 Conformity assessment and GSPR
Module 2: Software development
Module 2.1 Introduction to software development
Module 2.2 Risk and security management
Module 2.3 Software design and implementation
Module 2.4 Verification and validation
Module 2.5 Traceability and configuration management
Module 2.6 Feedback and change control
Module 3: Technical Documentation (bonus)
Module 3.1 Set-up of Technical Documentation

למי זה מתאים?

QA/RA professionals, Product developers at manufacturers, PRRCs, and anyone within companies developing SaMD or software as an integral part of equipment.

מה אקבל מכך בפועל?

Participants are:

Enquired with an in-depth understanding of essential regulatory frameworks and international standards (MDR/IVDR, IEC 62304, and IEC 82304-1)
Trained in implementing software development life-cycle principles like cybersecurity practices
Equipped with practical skills to drive secure software development within their organizations.
Integrating theoretical knowledge with practical application

This training empowers trainees to significantly enhance their contributions to medical device software development, elevating the quality and regulatory adherence of their projects.