Personal Information
Entreprise/Lieu de travail
Stockholm, Sweden Sweden
Profession
Co-Founder and CEO
Secteur d’activité
Medical / Health Care / Pharmaceuticals
Site Web
http://www.qadvis.com
À propos
My focus and interest is on how to combine Lean and Agile methods with regulatory expectations for Medical Device software.
I see a great potential to gain quality and productivity picking the best practices from Lean and Agile. These techniques can contribute to high quality, usability, safe architecture in combination with short time-to-market for new products and features. We need of course to use the techniques correctly.
Risk Management is central in the regulatory expectations. It can be challenging to make it work in a software department.
The basis for efficient software validation is a solid and efficient Quality Management System. Proper IT infrastructures make things much
Mots-clés
medical device
mdd
62304
lean
software
14971
fda
risk management
ce mark
agile
risk manager
60601
network
80001
it
iso 9001
quality system
harmonized standard
qsr
iso 13485
qms
riskhantering
mjukvara
medicinteknik
scrum
Tout plus
Présentations
(5)J’aime
(2)Agile Development And Medtech
Robert Ginsberg
•
il y a 13 ans
ISO/IEC80001 - Do we need another standard?
Robert Ginsberg
•
il y a 13 ans
Personal Information
Entreprise/Lieu de travail
Stockholm, Sweden Sweden
Profession
Co-Founder and CEO
Secteur d’activité
Medical / Health Care / Pharmaceuticals
Site Web
http://www.qadvis.com
À propos
My focus and interest is on how to combine Lean and Agile methods with regulatory expectations for Medical Device software.
I see a great potential to gain quality and productivity picking the best practices from Lean and Agile. These techniques can contribute to high quality, usability, safe architecture in combination with short time-to-market for new products and features. We need of course to use the techniques correctly.
Risk Management is central in the regulatory expectations. It can be challenging to make it work in a software department.
The basis for efficient software validation is a solid and efficient Quality Management System. Proper IT infrastructures make things much
Mots-clés
medical device
mdd
62304
lean
software
14971
fda
risk management
ce mark
agile
risk manager
60601
network
80001
it
iso 9001
quality system
harmonized standard
qsr
iso 13485
qms
riskhantering
mjukvara
medicinteknik
scrum
Tout plus