Medical Device Product Life Cycle
- BOOSTING MEDTECH KNOWLEDGE TOGETHER!
8-9
OCTOBER
2024
Stockholm, Sweden
Join our Medical Device Quality Assurance and Regulatory Affairs conference on the 8-9th of October in Stockholm, Sweden. This is an international conference focused on navigating the world of medical device regulations and standards. Our speakers will share their knowledge and tools to help you make complex things easier!
We will outline strategies, 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.
This is a must-attend conference for professionals working with product safety, as Quality or Regulatory specialist, with design and development, clinical/ performance evaluations, post-market-clinical follow-up activities, process development or Quality Assurance/Regulatory Affairs.
What will you learn?
- 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!
Who is it relevant for?
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
Preliminary agenda
Click a title for information about the presentation and speaker
DAY 1
09.00-17.00 CET
09.00
Welcome!
Jan Hellqvist, CEO – Key2Compliance
The user perspective
TBC
Medical Device development
TBC
- Usability; differences between US and EU requirements
- Intended purpose (use) – how detailed should it be..?
- Technical Documentation – structure and story (managing different versions, change control, structure and traceability…)
- Change management and how to use Design Review as tool
Summery – End of day 1
17.00
Networking
Drinks, snacks and get-together
DAY 2
09.00-17.00 CET
09.00
Opening of day 2
Workshops:
- Things to consider for international product registrations – (regulated vs unregulated markets)
- Outsourcing – what is sufficient level of control
- Filing a 510k – what does it take?
- Working with non-EU distributors – key aspects of the distributor contract and how to maintain control.
Being a medical device distributor
TBC
Panel discussion :
How to connect the ends, ensure exchange of information at the right level – relevant, correct, efficient communication to promote patient safety
16.45-17.00
Closing remarks
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 venue & facts
The 2-day conference will take place in Stockholm, Sweden at “7A Posthuset” next to the Stockholm Central station.
Directions to the conference will be provided after registration.
Accomodation is not included in the registation fee, but there are several nice hotels located close to the venue.
Hotel recommendations will be provided after registration.
After the last session on the 8th of October, all attendees are invited to a networking get-together where refreshments and drinks will be served.
Price: 990 EUR/person
Early bird registration until June 30th: 890 EUR/person
Discount: 3 persons or more if registered and invoiced together: 10%
EXHIBITOR
PACKAGE
- Max 8 Exhibitors
- Company logo on Key2Compliance web sites with click-through capability
- Exhibit space at the event (Size 2 x 1 m)
- Special recognition as sponsor and distribution of your marketing materials during lunch
- Two event passes
PRICE:
€2500
Contact us
If you wish to know more – Send in the form and we will help you
