Medical Device Product Life Cycle Conference

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

Agenda (For detailed agenda Click here →)

• My everyday life, as dialysis patient
• Medical Device development
• How to make the Design Review really valuable
• How to prepare for the NB Audit – my best tips from a vast audit experience
• Your MDR Technical Documentation submission: three success factors, plus a mistake you should avoid!
• Harmonization of Medical Device Regulations – current initiatives by IMDRF, and the ‘Global Harmonization Working Party’
• Medical Device Product Life Cycle from the Perspective of a Medical Device Testing Laboratory – Biocompatibility, Cleanliness, Single / Repeated Processing
• Outsourcing and Supplier Control – what the MDR requires
• Product liability throughout the medical device supply chain: a changing landscape
• Product Lifecycle Management’, a recipe to maintain regulatory compliance
• What is important to a Notified Body in the post market surveillance of a device?
• Being a medical device distributor
• Workshops
  • 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
  • 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

Conference facts

Date & Time

October 8-9th, 2024
Day 1: 09.00 – 17.00
Day 2: 09.00 – 17.00

Location/Venue

The 2-day conference will take place in Stockholm, Sweden at “7A Posthuset” in the city center. Directions to the conference will be provided after registration.

Accommodation

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

Conference mingle

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.

Conference fee

995 EUR/person
The fee includes full participation at conference, get-together mingle and electronic copies of conference notes.
Discount: 3 persons or more 10% if registered and invoiced together.

Note: Due to EU Directive 2006/112/EC local VAT (25%) is added. (See also: Council Implementing Regulation (EU) No 282/2011).
This VAT is refundable for tax registered companies. More information (PDF) →

Exhibitor package

Price: 2500 EUR

• 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

Contact us for more information: info@key2compliance.com

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