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 exercises

The course is developed in collaboration with the scientific section for Medical Devices at Swedish Pharmaceutical Society.

All lectures will be held in English.

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 (SaMD) and safety assessment of Medical Devices. His most recent position was that of Senior Expert at the Swedish Medical Products Agency, participating in EU committees NBOG and COEN, represented EU in IMDRF Software as Medical Devices working Group and member in a number of IEC/CLC and ISO/CEN standardization committees. Trained auditor and assessor for medical device manufacturers and Notified Bodies. Currently an independent consultant, Mats Ohlson MT-Advisor, offering regulatory advice for manufacturers, developers, users, authorities and others. Mats is also a member of the board of Apotekarsocieteten, Medical Device section.

Time and venue and accommodaton

The course is held at Apotekarsocieteten, Wallingatan 26A in Stockholm.

• Day 1 from 09.00-16.00
• Day 2 from 08.30-16.00

For Accommodation, we recommend Scandic hotel Norra Bantorget. Wallingatan 15, Stockholm.

Participation fee

11.500 SEK until November 05 2019 and 13.800 SEK from November 06. Digital 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.

Registration

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.

Participant list

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.