MDR Transition Training: Enhance the Standards on Quality & Safety Measures.

In order to help medical device manufacturers understand the additional requirements of the regulation, there has been introduced an MDD to MDR Transition Training Course. Let’s learn all the possible details about the course.

If you are engaged in a medical profession anyhow, you would be aware that Medical Device Directive (MDD) will be replaced by the new Medical Device Regulation (MDR) on 26 May, 2021. MDR is designed to be an enhanced version of MDD, with the major difference being that MDR impacts and provides effectiveness to all EU member states. This allows MDR to offer a regulation that is consistent and fair to all member states, improving the standards on safety and quality measures. But for those who are confused with the changes, there is MDD To MDR Transition Training Course. The course provides details of the new MDR that is replacing the existing MDD and AIMDD.

MDR Transition Training course is primarily intended for enterprises that already manufacture products against the existing MDD. It can be delivered as either a public or in-house event but is seen as especially attractive as in-company where the content can be modified to suit the needs of the organization.

Target Audience: who should attend?

Individuals and professionals responsible for regulatory compliance and working in an organization involved in many aspects of medical device designing, manufacturing, marketing or the supply chain.

· Regulatory personnel

· Managers

· CFOs

· CEOs

· Medical device industry employees

· Medical device users

· Anyone who is interested in Medical Device Strategy Consulting wants to learn about the new regulation

Topics covered in the training

· Introduction to MDR

· MDD Background

· MDR Implementation Strategy

· Quality Management System & EU-MDR Requirements

· General Safety & Performance Requirements

· Challenges

· Technical Documentation

· Notified Bodies

What will you learn?

· The MDR’s additional requirements

· The current directives of MDD 93/42/EE and ISO 13485:2016

· Terminology and certification requirements

· The European regulation CE marking approach for medical devices including its operational and legal basis

· The scope and structure of the MDR including conformity and classification routes

· The performance and safety requirements checklist

· You will learn to create technical documentation to support the product throughout its life cycle

· The regulatory significance of robust risk management and quality management system

Now when you know little insight about the training and its importance, approach the qualified professionals with extensive expertise to get the proper training.