Medical Device
Product Life Cycle

26-27 OCTOBER 2022 • LUND, SWEDEN

Make compliance your success factor

Join our international two-day conference, which address key aspects on how to maintain device performance and compliance, throughout the product life cycle.

Our speakers will outline strategies for the pre- and post-market activities needed to evaluate and demonstrate device safety and effectiveness during the entire product life cycle. Starting from user needs, through design, manufacturing, and a proactive post-market surveillance, in close collaboration with your key stakeholders.

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WHAT

  • A conference with a real life cycle approach, on medical device quality and regulatory processes
  • An opportunity to deepen your understanding on responsibilities of, and relationships between, economic operators
  • Presentations, interactions, and workshops that will give new insights and tools, for your daily work!

WHY

  • Stay in top of the latest interpretations of the regulations!
  • Listen and learn from some of the most experienced experts within the industry
  • Broaden your understanding, learn new skills and expand your professional network!

WHO

Professionals working with:
  • Product safety, as Quality or Regulatory Design and development
  • Clinical/ performance evaluations
  • Post-market-clinical follow-up activities
  • Process development
  • Quality Assurance/Regulatory Affairs

This conference will include

2 Days

Networking

Expert speakers

Workshops

AGENDA

Click each title for a short summary and speaker presentation.

Day 1

9.00

Welcome!
Jan Hellqvist, CEO – Key2Compliance
Magnus Fyrfalk, Moderator – Fyrfalk.se

9.50

Break

11.20

How does the industry succeed in meeting user needs, in design, delivery and communication? A caregivers perspective.
TBD

12.00

Lunch

13.55

Usability – how to implement it from scratch!
Workshops held in three areas:
• Software,
• In-Vitro Diagnostics
• General Medical Devices

14.45

Break

16.45

Summery – End of day 1
Magnus Fyrfalk, Moderator – Fyrfalk.se

17.00

Networking
Drinks, snacks and get-together

Day 2

8.45

Opening of day 2
Magnus Fyrfalk, Moderator – Fyrfalk.se

10.10

Break

12.00

Lunch

13.00

Efficient and sufficient PMCF/PMPF
– Workshops held in three areas:
• Software
• In-Vitro Diagnostics
• General Medical Device

14.45

Break

16.00 – 16.45

Panel debate:
How can the medical device stakeholders work together, to reduce risk and promote innovation?

Our Speakers - The experts are here

We are honoured to welcome some of the industry’s best and most
experienced to the stage for interesting and learning presentations.

Conference

Conference venue & facts

The 2-day conference will take place in the city of Lund in the south of Sweden at the Medicon Village, a Life Science Park.
40 min from Copenhagen Airport and 15 min from Malmö C. Directions to the conference will be provided after registration.

Hotel

Accomodation is not included in the registation fee, but there are several nice hotels located close to the Medicon Village. Hotel recommendations will be provided after registration.

Mingle

After the last session on the 26th of October, all attendees are invited to a networking get-together where refreshments and drinks will be served.

ikon-euro-light

990 EUR
Discount: 3 persons or more 10% if registered and invoiced together.

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