MDR: Document control made easy

Fr 28.06.2024
10:00 am - 11:00 pm

Whether Device Master Record (FDA), Medical Device File (ISO 13485:2016) or technical documentation (MDR): Current regulatory provisions require a master file that describes exactly how a medical technology product should be manufactured, used and maintained.

Given the large amount of information required, paper-based procedures are increasingly reaching their limits. The consequences: lengthy searches for documents, outdated versions and expired approvals.

How you can meet these strict requirements efficiently and safely with the KUMAVISON industry software for medical technology and our new MDR module We will show you how to implement this with numerous practical examples in this webinar.

The content of this webinar

  • Many document types, one storage location: Thanks to DMS integration, you can manage a digital master file with technical drawings, assembly and production instructions, general terms and conditions, test plans, certificates or packaging regulations directly in the KUMAVISION industry software in an audit-proof manner and without double data maintenance.
  • The right document in the right place: Whether production, purchasing, sales or service – we will show you how you can automatically integrate documents into your business processes and reuse them in a variety of ways, e.g. B. print directly with your receipts.
  • Articles subject to approval: Do you want to ensure that certain items can only be sold in approved countries? That items can only be purchased from selected suppliers? Find out how easy it is to set up and manage the feature requiring approval with KUMAVISION.
  • Safe transition from MDD to MDR: How you can prepare your master data for products already approved according to MDD for the MDR in advance and automatically convert it on the deadline.
  • All admissions and dates at a glance: We'll show you how you can use KUMAVISION to not only manage approvals and certificates, but also plan their renewal safely - including a reminder function, task assignment and status overview at the touch of a button

target audience

The webinar is aimed at all companies in the regulated environment that manufacture medical technology products and/or place them on the market as dealers.

Speakers

Roland Borner is a consultant at KUMAVISION. His focus is on industry solutions tailored to medical technology with over 350 best practice processes. The basis of his work as a consultant is practical relevance and customer orientation. He likes to incorporate his experience into his lectures. > LinkedIn profile

Philip Wilde (presenter) advises and supports medium-sized companies in digital transformation with a focus on ERP and CRM industry software and is your first point of contact for ERP projects in the areas of medical technology and the healthcare market. > LinkedIn profile

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Register now for this webinar free of charge and find out how you can easily and securely map the regulatory requirements of the MDR with KUMAVISION industry software.

 

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