Medical Device User Group Sweden

Medical Device Network Group - GDPR and Cloud

Join us at Carmeda AB to explore these challenges

November 15, 08:15 - 10:30 (Morning fika)
Hosted by Carmeda AB
Kanalvägen 3 B, SE-194 61 UPPLANDS VÄSBY, Sweden
Click here to join your peers - and pass the invite to your colleagues!

Want to discuss challenges with peers in the Swedish Medical Device community? Join this Medical Device Network Group, designed to increase insight by bringing you together with subject-matter-experts and your peers. This meeting, (second in the series), tackles two topics, which were selected by the network group at the previous meeting: GDPR (General Data Protection Regulations) and Cloud Computing. It is designed for Medical Device QA, RA and IT professionals, as well as system owners and data owners.

Agenda:

- Introduction: Purpose of Medical Device Network Group - and motivation for choosing these topics
Malin Edblad, Scientist at Carmeda AB

- GDPR: What you need to know
Johan Förander, Attorney at Law, Partner at Norra Vall Advokater

This presentation will focus on the practical aspects of GDPR.
- The major GDPR principles and how they can make you work smarter.
- 6 months left: Your main issues before May 25, 2018.
- How to comply - including sensitive data and International processing.
- Questions and discussion will be welcome throughout the presentation.

- Cloud Computing: Practical Experience from the regulated Life Science industry
Robert Pettersson, Managing Director, Epista Life Science - Sweden

We'll discuss staying in control while ‘going cloud’ in a regulated environment.
- Exploit the benefits of a cloud environment while mitigating the disadvantages.
- Practical considerations: How do we stay in control of services and data? What are the authorities’ requirements? How do we ensure IT security, availability and reliability of data? How do we ensure business continuity?
- Spoiler alert: Answers to these questions involve strong agreement frameworks and governance models for the entire life cycle.
- Questions and discussion will be welcome throughout the presentation.

- Wrap up and discussion of topic for next meeting
Malin Edblad, Scientist at Carmeda AB

 What is the Medical Device Network Group all about? 

The group was established to provide a space to network with peers and gain valuable inspiration, insights and operational tips for improving the quality and outcome of your organization’s compliance efforts. In the first meeting, we discussed why and how to create an IT Compliance Plan that includes validation of computerized systems, control of legacy systems, qualified IT infrastructure, and accounts for the new focus by FDA and global regulatory authorities on data integrity. We also discussed a methodology to measure compliance so you can identify concrete tasks to tune your efforts to the optimal level. You can read about it and view the presentation here. 

Whether you joined the first meeting or want to join for the first time, you as a Life Science professional in Sweden are welcome to be a part of this user group. The group is designed for professionals in QA, RA, IT, system owners, and data owners.

Note: This is an open invitation for industry practitioners. If you fall into this category, please share with colleagues and other relevant people in your network. (Remember registration). This event is not open to consultants or vendors.

Join your peers! Register here:

E-mail invitation, LinkedIn, Colleague, or some other way?