Building Compliance through PLM - Current Challenges and Trends in Device Development

April 15th - 16th in Copenhagen

We invite you to a co-hosted 2-day event at MVA & William Demant Holding's headquarters in Copenhagen. This event is the forum for PLM in medical device, diagnostics and drug development, where we discuss and benchmark important issues and challenges in your daily work. Additionally you will influence Technia’s strategy and future solutions for the life science industry.

 

Day 1: Building Compliance through Device Development Excellence 

This half-day is an introduction to Product Lifecycle Management (PLM) for Device Development – covering key device development, quality, regulatory, prototyping and sourcing and manufacturing processes  - Why and how PLM is introduced to reduce lead time in these processes.

When: April 15th, 12:00 - 17:00

Where: Medicon Valley Alliance’s office in Orestad, Copenhagen

New Address: Edvard Thomsens Vej 14. - 2300 Ørestad City – Denmark, www.mva.org

Format: Presentations, live demonstrations and roundtable discussions

Intended Audience: Intended for you who are new to PLM for global device development but would like to understand hands-on functionality and how it is applied to design controls and related processes.

In the evening we host a dinner in downtown Copenhagen at Nimb Brasserie together with Technia Life Science Customer Advisory Board – a good opportunity to network with experienced users from WDH, GE Healthcare, Mölnlycke Health Care, Elekta, among others.

Agenda

12:00 - 15:00    
Intro (while having lunch)
- Building Compliance through Device Development Excellence 
- The essence of PLM – one version of the truth for global development

- What does it mean to different roles in the device development organisatin

Example Processes and Application Areas (Selected Live Demonstrations):
-    Ideation and concept development
-    Claims management
-    Modular management and variant configuration
-    Global product change and DMR management
-    Design controls, DHF, program and project management
-    CAD vaulting with Solidworks (or any other CAD)
-    Requirements to validation management
-    Systems engineering (RFLP)
-    Complaints to adverse events reporting to CAPA to Change
-    Controlled documents
-    Global market access – product compliance
-    Submissions, technical file/dossier and UDI

15:00 – 15:30 Coffee Break

15:30 - 17:00
PLM  – Implementation 
-    What scope is relevant to us?

  • Roadmap and Dependencies
    -    PLM is business transformation - Change management
    -    Validation 
    -    Fit with QSR, MDD and FDA requirements

17:00    End

19:30     Dinner at Nimb Brasserie, Tivoli, Bernstorffsgade 5, Copenhagen

Day 2: Current Challenges and Trends & Technia Life Sciences Customer Advisory Board

This full-day session at William Demant Holding goes in depth on selected topics PLM for life sciences – The morning session is open and relevant for both existing ENOVIA customers, non-ENOVIA users, or people completely new to PLM. The afternoon is the ENOVIA user community only - with the Life Science Customer Advisory Board – the forum to debate challenges, network, give feedback and shape PLM and Technia for tomorrow – for a better life science PLM future. The day ends with the introduction to the new ENOVIA 2015X and TVC 2015.1 releases

When: April 16th, 09:00 - 16:30

Where: Kongebakken 9, DK-2765 Smørum - Denmark

Format: Presentations, live demonstrations and roundtable discussions

Intended Audience: Morning session intended for both users new to ENOVIA as well as existing ENOVIA customers, whom would like an in depth review on the selected key topics. The last session in the afternoon is for ENOVIA customers only.

Agenda

08:30   Coffee & Registration

09:00 - 09:30   Welcome & Introduction

09:30 - 10:15   Challenges and Trends in PLM for Medical Device Development

  • UDI PLM Readiness and Current Challenges

10:15 - 10:45   Coffee Break

10:45 - 12:30   cont. Challenges and Trends in PLM for Medical Device Development

  • DHR and Manufacturing Excellence in PLM
  • Product Update 3DEXPERIENCE Release 2015x: ENOVIA 2015x and TVC 2015.1

12:30 - 13:30    Lunch

13:30 - 15:00    cont. Challenges and Trends in PLM for Medical Device Development

  • Sales and Variant Configuration for Device Development
  • Search Capabilities – a new generation
  • 14:30 Coffee, Ideation & Appreciation

15:00 - 16.30    Life Science Customer Advisory Board

  • Advisory Session – Forum and Feedback

16:30    End

 

This event is free of charge. We do however charge a fee of 1500 DKK for no-shows.

 

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