Clinical Evaluations for Unique Product Types Under the EU MDR - Webinar

Celegence (www.celegence....) provides the medical device industry with consulting services that are tailored to the evolving needs of manufacturers.
Our suite of services including EU MDR related support allows you to focus on your core responsibilities. With our guidance, bringing your devices to the market and keeping them there will be easier for your regulatory and quality teams.
Manufacturers of medical devices must carry out a clinical evaluation of their products in order to be allowed to market them in Europe. To do this, the manufacturer must use clinical data to confirm that the medical device is safe and functions as intended. The manufacturer then assesses whether the risks of use are in a reasonable proportion to the expected benefits.
Learning Objectives:
The webinar will detail and cover the following items:
1. Overview of CE requirements for EU MDR Compliance
2. Updates on regulations and guidance documents
3. Combination Products
4. Software as a Medical Device (SaMD)
5. Legacy Devices
6. Strategy and approach to consider for specific product types
7. Q/A with panelists from TUV SUD, industry manufacturer, and Celegence experts
For more information on how we can help you with EU MDR reach out to us at [e-mail], contact us online or read more about Celegence’s medical device capabilities.