Medical Device Product Life Cycle

26-27 October 2022 | Lund, Sweden

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.

Who is it for?

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.

Agenda at-a-glance

Day 1 

• Medical Devices as part of your daily life -the User perspective
  Sofia Segersson – Diabetesia
• How the industry work to meet both user needs and expectations from the buyers
  Josef Smeds – NordicInfu Care
• From user need to product specification – real world example
  Christoffer Ekström – AI Medical Technology
• Being the ‘Person Responsible for Regulatory Compliance’ – is this in fact a quality control, regulatory affairs, or both
  Åse Ek – Key2Compliance
• Future-proof your device – How to manage changes in regulations and standards over the product life cycle
  Emma Glass – BSI
• Usability – how to implement it from scratch!
  Workshops held in three areas: Software, In-Vitro Diagnostics, General Medical Devices
• Cybersecurity: How to deal with it throughout the Medical Device lifecycle?
  Cyrille Michaud – MD101 Consulting
• Global trends within medical device regulations
  Erik Hansson, Senior Expert in Global Harmonisation of Medical Device Regulations
• Networking – Drinks, snacks and get-together

Day 2 

• Design transfer and contract manufacturing of medical devices – Practical tips and examples to mutually working relationship between customer and contract manufacturer
  Antti Virtanen, Solution Architect – Innokas Medical
• How legal manufacturers shall control their contract manufacturer – an NB perspective.
  Jocelyn Åkerlund – Stille Medical AB
• Interaction between manufacturers and other economic operators: How to effectively implement PMS in the supply chain
  Judith De Wilde – Axon Lawyers
• Post-Market Surveillance and Vigilance, and the links to Clinical Evaluation and Risk Management
  Jacques Thielen – Senior Consultant and expert in Regulatory Affairs and Post-Market Surveillance
• Efficient and sufficient PMCF/PMPF
  Workshops held in three areas: Software, In-Vitro Diagnostics, General Medical Devices
• How can device manufacturers meet user needs? Reflections from healthcare perspective
  Magnus Tägil – Skåne University Hospital
• ‘Marketing & Claims: How marketing, clinical evaluation and other MDR processes intertwine‘
  Judith De Wilde – Axon Lawyers
• Panel debate: How can the medical device stakeholders work together, to reduce risk and promote innovation?

Learn more about the conference

Our 2-day conference will be full of presentations, interactions, and workshops that will give new insights and tools, for your daily work! Learn more about the conference by visiting the “Medical Device Life Cycle Conference” presentation page.

INFORMATION AND AGENDA →     SPEAKERS AND PRESENTATIONS →

How to register

Be sure to secure your seat and register now for the conference by clicking the “ADD TO CART” button above.

Buy your ticket : 990 EUR – There is also a 10% discount for 3 persons or more if registered and invoiced together.

We look forward to meet you in Lund on the 26-27^th of October!

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