A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

Supplier Management with the new Medical Device Regulation EU MDR 745/2017 – Webinar

The “Supplier Management with the new Medical Device Regulation EU MDR 745/2017” webinar has been added to ResearchAndMarkets.com’s offering.

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the supply chain and the interfaces to the EN ISO 13485:2016.

Both, the ISO standard and the MDR requires for outsourced processes additional activities and be careful with outsourced processes. Those are not only on the classic supplier side. Those are also on the other side of the company in the area of sales and post market activities. The understanding of this changes and how to implement is essential to keep your certificates.

You should attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. Your implementation need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

The webinar will describe the following vital topics:

  • Introduction, who must apply the new EU MDR 745/2017 requirements
  • Overview about the changes of the EU MDR 745/2017 regarding supplier and outsourced activities.
  • Explaining of each change
  • Smart and fast ways to implement the changes in your quality management system
  • Fast track internal audit to approve the changes
  • Who is responsible for the activities?
  • Which (new) roles in the company required?

Who Should Attend:

CEO’s, purchasing manager, quality/regulatory affairs manager, quality representatives of medical device manufacturers, importers, distributors, and dealers who work with European Union, European Economic Area, Switzerland, Turkey

Key Topics Covered:

  • Closer regulatory binding of the ISO to the new EU MDR
  • Responsibilities for outsourced processes
  • What are outsourced processes?
  • Adjustments in the management review
  • Adjustments in the audit process
  • How to onboard the supplier?
  • Examples from outsourced R&D-, manufacturing-, lab-test – processes
  • Examples from outsourced sales processes

For more information about this webinar visit here.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy