My 28.05.2025
10:00 am - 11:00 pm
Ob Device Master Record (FDA), Medical Device File (ISO 13485:2016) oder technische Dokumentation (MDR): Aktuelle regulatorische Bestimmungen verlangen eine Stammakte, die genau beschreibt, wie ein medizinisches Produkt hergestellt, genutzt und gewartet werden soll.
In medical technology, the management of approvals and other documents is closely regulated by the FDA, ISO 13485 or the MDR. Companies are looking for ways in which software can support them here.
As a provider of the industry solution KUMAVISION medtec365 we have a solution that we will present to you in this webinar.
Profitieren Sie von Vorteilen wie:
- Shortened search processes
- Frei strukturierbare Dokumentenhierarchie
- Gültigkeitsüberwachung
- Storage of all documents in one place through integration of the ECM system
- Arbeitsersparnis durch automatisierten Versand von Dokumenten mit Belegen
Learn how to easily digitize and automate paper-based handling.
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.
- 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
Das Webinar richtet sich an alle Unternehmen im regulierten Umfeld, die Medizinprodukte fertigen und/oder als Händler in Verkehr bringen.
Speakers
Ingo Dorrie Ingo Dörrie has more than 25 years of experience in the digitalization and automation of companies. Coming from East Westphalia, he has advised national and international companies or pushed digitalization and automation as CIO, project manager and designer. In keeping with the topic of this webinar, its focus today is on people who use information technology as a tool and use standards to automate routine processes. Obtaining high-quality data and information is the basis for data-driven decisions. > LinkedIn profile
Philip Wilde (presenter) advises and supports medium-sized companies in digital transformation with a focus on ERP and CRM industry software. The focus is on the medical technology and healthcare market industry > LinkedIn profile
Registration
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.
