Rating 0 out of 5 (0 ratings in Udemy)
What you'll learn- Gain a detailed overview of the MDR.
- Understand the key components of MDR Compliance.
- Learn the secrets to generating, identifying, appraising and analysing clinical evidence for medical device compliance.
- Access powerful resources and personal support that will complement your internal capabilities in working with the MDR.
- Build active regulatory systems that will safeguard your MDR transition through targeted knowledge and …
Rating 0 out of 5 (0 ratings in Udemy)
What you'll learn- Gain a detailed overview of the MDR.
- Understand the key components of MDR Compliance.
- Learn the secrets to generating, identifying, appraising and analysing clinical evidence for medical device compliance.
- Access powerful resources and personal support that will complement your internal capabilities in working with the MDR.
- Build active regulatory systems that will safeguard your MDR transition through targeted knowledge and understanding.
- Get beneath the skin of the EU MDR and understand the key requirements for medical device compliance.
- Confidently build active regulatory systems to MDR standard.
- Turn regulatory obligations to your wider advantage.
- Generate and interpret clinical evidence to support your MDR submissions.
- Access powerful resources and personal support.
DescriptionSuccessful MDR compliance is demonstrated by the application of a CE-mark to the device. Class I manufacturers (except for devices that are sterile or have a measuring function) may self-apply a CE-mark after producing a declaration of conformity. For all other classes of medical device, a CE-mark may only be affixed once a Notified Body has issued a certificate of conformity following a regulatory review according to rules in Chapter IV of the MDR.
This modified webinar will allow medical device manufacturers and suppliers to benefit from our unique knowledge and insight of working with the Medical device Regulation. The lecture is aimed at suppliers and manufacturers of medical devices from across the industry, and will give you an empowering perspective on working successfully with the MDR. With our MDR Masterclass you will be able to get beneath the skin of the EU MDR and understand the key requirements for medical device compliance.
We will teach you how to build active regulatory systems that will safeguard your MDR transition through targeted knowledge and understanding. Learn the secrets to generating, identifying, appraising and analysing clinical evidence for medical device compliance as well as accessing powerful resources and personal support that will complement your internal capabilities in working with the MDR.
