Managing Compliance and Requirements for Medical Device Solutions

 

Join us at this breakfast seminar, brought to you by InnoFour, a Siemens Expert Partner, in collaboration with Siemens Digital Industries Software, Thursday September 21, 2023.

 

Listen to the interesting presentation by: Christina Espersen - Coloplast Denmark: 'Digitalizing design control and risk management documents for existing and new product portfolios'.

 

Medical device product development has been a foundational element of the practice and betterment of medicine for about as long as mankind has been trying to heal people. Over the millennia, our medical devices have become more complex and powerful, and the same can be said for the regulatory environment.

 

Medical device risk management needs to be a living process that becomes a granular part of the entire product development process. Many of the challenges around risk management comes from using old technology – static written documents and spreadsheets – to track the complex and dynamic environment.

 

Traceability is the foundation of medical device risk management. A robust requirements management solution can support workflows and traceability through the design manufacturing and risk management relationships.

 

This breakfast seminar will address the challenges of complying with Medical Device Regulations and shows how it's possible to maintain speed and quality in development projects in the Medical Device Industry.

 

 

What you will learn:

 

First of all, this is an opportunity for you to get inspired and bring back to your organization what you thought was valuable. Our distinguished experts will explain to you:

• Benefits of an effective risk management strategy for medical devices
• Optimization of traceability in medical device risk management
• Importance of implementing a solid risk management model
• Defining key documents for medical device risk management

We will of course reserve a timeslot for Q&A in the end, and you can always talk to our experts after the seminar.

 

Details

 

What

Live Breakfast Seminar: Managing Compliance and Requirements for Medical Device Solutions, Breakfast Meeting

 

When

Thursday, September 21, 2023

 

Where

Clarion Hotel Copenhagen Airport
Ellehammersvej 18 - 20
2770 Kastrup - Denmark

 

Time

08:30 - 11:30 hr CET