PROCESS FELLOWS - AUTOMOTIVE SPICE - FUNCTIONAL SAFETY - PROJECT MANAGEMENT
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Process Fellow at MedConf 2022 - "Medical SPICE - Qualification of users and assessors"

                                                                                                                                                                                                                                                    April 26, 2022
This year, MedConf 2022 will once again take place in Munich from May 10-12, 2022, in a hybrid format - i.e., both on-site and online - and addresses employees and executives of medical technology companies, particularly those from the areas of research & development, quality management, product development, regulatory affairs, and so on. Every year, around 250 participants attend the conference.
 
Our Process Fellow Bernhard Sechser will give a presentation together with Dr. Filipa Campos-Viola (FSQ Experts GmbH) on May 11 at 2 pm:
 
Medical SPICE - Qualification of users and assessors.
(VDI-MT 5702 Part 2)

 
Already more than 20 years ago it was predicted that the majority of future medical devices would include software. This prediction has not only been confirmed but has been surpassed in complexity by using new technologies, such as artificial intelligence. One consequence is that the medical device manufacturers must define detailed software development processes which must be adapted to the use of the new technologies. Experience from other industries, e.g., the automotive industry, shows that the maturity of a development process is an indicator for the quality and safety of the final product.
 
The guideline VDI 5702 Part 1 "Medical Device Software – Medical SPICE Process Assessment Model" has already providing for some time an evaluation model that covers the most important requirements for the development of such a product, e.g., according to IEC 62304. This enables medical device manufacturers to assess the maturity of their own development processes or those of their suppliers. But what knowledge is required to properly understand and apply this model? How can medical device manufacturers educate and empower their employees? Who is allowed to perform such a Medical SPICE assessment? And can assessors with experience from other industries successfully be used in medical device domain?
 
In this presentation, the two speakers will present the guideline VDI-MT 5702 Part 2 "Medical Device Software – Medical SPICE – Qualification of Developers and Assessors", which tries to answer these questions.
 
What will the audience learn in the presentation?
  • Introduction/insight into the guideline VDI-MT 5702 Part 2.
  • Requirements for the qualification of users of the guideline VDI 5702 Part 1
  • Qualification of assessors regarding the "Medical SPICE PAM"

The conference will be held in German language.
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    • Automotive SPICE® >
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        • intacs®​ ​Automotive SPICE®​​ 4.0 ​Upgrade Training
        • intacs®​ Certified Process Expert (Automotive SPICE®​
        • intacs®​ Certified Provisional Assessor (Automotive SPICE®​ V4.0)
        • intacs® Certified Process Expert und Provisional Assessor Automotive SPICE® kombiniert
        • intacs®​ Certified Competent Assessor (Automotive SPICE®​)
        • intacs® certified Automotive SPICE®​ Cybersecurity Engineering
        • intacs® certified Automotive SPICE®​ Hardware Engineering
        • intacs® certified Automotive SPICE®​ Machine Learning
        • intacs® Einführung in die VDA ​Automotive SPICE® Guidelines
        • intacs® Certified Automotive SPICE® Potential Analysis Training
      • Andere >
        • Automotive SPICE® im Überblick
        • Automotive SPICE® - A Practical Introduction
        • Automotive SPICE®​ und Funktionale Sicherheit - kombiniert
    • Hardware SPICE >
      • intacs® certified Automotive SPICE®​ Hardware Engineering
      • Hardware SPICE: A Practical Introduction
    • Mechanical SPICE >
      • Mechanical SPICE: A Practical Introduction
    • Weitere SPICE Trainings >
      • intacs®​ ​ISO/IEC 33061 ​Upgrade Training
    • Funktionale Sicherheit >
      • Funktionale Sicherheit im Überblick
      • Einführung in die Funktionale Sicherheit
      • Automotive SPICE®​ und Funktionale Sicherheit - kombiniert
      • Personen Qualifizierung ISO_26262
    • (Cyber-)Security >
      • intacs Schulung für das „Automotive SPICE® for Cybersecurity” Modell
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        • intacs® Certified Process Expert and Provisional Assessor (Automotive SPICE®​ V4.0) - combined
        • intacs Certified Competent Assessor (Automotive SPICE)
        • intacs® certified Automotive SPICE®​ Cybersecurity Engineering
        • intacs® certified Automotive SPICE®​ Hardware Engineering
        • intacs® certified Automotive SPICE®​ Machine Learning
        • intacs Introduction to the VDA Automotive SPICE Guidelines
        • intacs®​ ​Certified Automotive SPICE®​​ Potential Analysis Training
      • Other >
        • Automotive SPICE® in a Nutshell
        • Automotive SPICE® - A Practical Introduction
        • Automotive SPICE®​ and Functional Safety - combined
    • Hardware SPICE >
      • intacs® certified Automotive SPICE®​ Hardware Engineering
      • Hardware SPICE: A Practical Introduction
    • Mechanical SPICE >
      • Mechanical SPICE: A Practical Introduction
    • Other SPICE Trainings >
      • intacs®​ ​ISO/IEC 33061 ​Upgrade Training
    • Functional Safety >
      • Functional Safety in a Nutshell
      • Introduction to Functional Safety
      • Automotive SPICE®​ and Functional Safety - combined
      • Personal Qualification ISO_26262
    • (Cyber-)Security >
      • intacs® Training for the "Automotive SPICE® for Cybersecurity" Model
      • Practices in Cybersecurity
      • A4Q Security Essentials
    • Systems Engineering >
      • Systems Engineering aligned with Safety, Security and SPICE
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