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?
The conference will be held in German language.
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.
