Software as a Medical Device – How to meet the new regulatory challenges
The course covers the regulatory requirements for software with a medical purpose. The instructors have several years of experience in the field and will share practical tips and strategies how to best meet the challenges.
Who should attend
Designers, QA/RA staff, R&D staff, Management, Marketing, Users
Course Content abbreviated
How to meet the requirements for CE-marking of software with a medical purpose?
Which are the requirements, today and tomorrow? MDD/IVDD, MDR/IVDR, GDPR etc
Guidances/standards. How to conform?
- IMDRF guidelines for Software as a Medical Device
- Quality management in Software development, EN 62304/82304
- Risk management acc. to EN 14971
- Usability acc. to EN 62366-1
- User network integration acc. to IEC 80001
- AI – Artificial intelligence
- Other useful standards/guidelines
Practical exercisesThe course is developed in collaboration with the scientific section for Medical Devices at Swedish Pharmaceutical Society.
Instructor - Micael Johansson, M.Sc.
Micael is a senior regulatory and quality consultant. Micael sits on the MEDEA board and consults to start ups and large companies in Europe. He is a member of the standard committee TK62. (TK62 handles the EN 60601 series) He has held many courses in Denmark and Sweden. His instruction is empowering and hands on. Micael is chairman of the board of Medical Device section at Apotekarsocieteten.
Instructor - Mats Ohlson, MSc Biomedical Engineering
Mats has extensive knowledge in the Medical Device sector with particular focus on Risk Management, regulatory aspects on medical information systems and safety assessment of Medical Devices. Areas of expertise are: CE-requirements for Medical Devices, Quality Management, Risk Management, Medical Information Systems (SaMD), Standardisation, Accident investigations, Communication, Teaching. His most recent position was that of Senior Expert at the Swedish Medical Products Agency. Here he actively participated in EU committees NBOG and COEN, represented EU in IMDRF Software as Medical Devices working Group and since long-term member in a number of IEC/CLC and ISO/CEN standardization committees. He is a trained auditor and assessor for medical device manufacturers and Notified Bodies. Mats is an independent consultant, Mats Ohlson MT-Advisor, offering regulatory advice in the medical device field for manufacturers, developers, users, authorities and others. He is also active as chairman of the board of the Medea Consultant Association and member of the board of Apotekarsocieteten, Medical Device section.
Time and venue
The course is held at Apotekarsocieteten, Wallingatan 26A in Stockholm.
- Day 1 from 09.00-16.00
- Day 2 from 09.00-16.00
11.100 SEK until November 11 2018 and 13.400 SEK from November 12. Documentation, certificate in digital format, lunch and coffee/refreshments are included. Printed documentation can be booked for an extra cost of 500 SEK. Excluding accomodation. All prices are excluding 25% VAT.
In order for us to offer all our participants the best possible service, please register your application no later than 72 hours before the start of the activity. When registering at short notice, please also contact the project administrator for the activity via email.
We usually share a list of participants during the first course day. Many participants request these lists when taking our courses and we see networking as an important part of the professional development. With reference to this, we assume that our participants have an interest in us sharing the list and the lawfulness of processing the personal data is therefore the legitimate interest. The lists contain first and last name and organization. If you do not want your name and organization to be included in the participant list, please notify the project administrator at the time of registration or else as soon as possible. If you have questions regarding the participant list, you are welcome to contact the responsible project administrator.
Coming events: Events in English
Software as a Medical Device - How to meet the new regulatory challenges
End date: 2018-12-12
No. of days: 2
Venue: Wallingatan 26A
Price: 11100 SEK
Price: 13400 SEK
All prices are excl VAT.
i Stockholm AB
111 81 Stockholm
Besöksadress: Wallingatan 26 A
Tel: 08-723 50 00
Fax: 08-20 55 11