Medical technology
Industry-specific solutions for Product Information Management (PIM)
Due to EU regulations (2017/745, Medical Device Regulation MDR), which will become valid from 2021, requirements for documentation of medical devices will be tightened. This includes classification rules (GMDN, UMDNS, CND, etc.), technical specification, accessories, interaction with other products, predecessor products, intended use, conformity assessment, clinical evaluation requirements, traceability, post-market data, and European database expansion.
MDR has doubled the documentation retention period from 5 to 10 years. All these measures have the consequence that digitization, in particular the management of product information in a centrally accessible database, with versioning and traceability, will become fundamental for manufacturers of medical devices. crossbase has strategically positioned the medical industry as a target group.
Central functions for your industry
- Management of approvals/registrations depending on region and approval type (CE, IEC, RZN, FDA, etc.).
- Management of registration data, including registration number, risk class, certificate number, submission date, date of registration, expiration date/validity, date for re-registration.
- Management of symbols, trade names and documents.
- Evaluation of whether the registrations required for a country are available for each item.
- Management and description of medical devices according to product categories, indications and medically relevant standard classifications.
- Management of medicine-specific documents, images and films such as instructions from the doctor to the doctor, reprocessing instructions, instructions, etc.
- Management of patents, standards and their meta data.
- Archive server: Functionality for backup and traceability of published information on the website and in printed sales documents.
Customers and reference reports
AniCon - SAN Group Biotech Germany GmbH
49685 Höltinghausen
Germany
Branch of industry: Medical technology, dental products, wound care
Sales category: 26 to 50 million €
ERP system:
Coltène/Whaledent AG
Coltène/Whaledent Inc.
9450 Altstätten
Switzerland
44223 Cuyahoga Falls, Ohio
USA
Branch of industry: Medical technology, dental products, wound care
Sales category: 251 to 500 million €
ERP system:
KARL STORZ SE & Co. KG
KARL STORZ Endoscopie France S.A.S.
78532 Tuttlingen
Germany
78280 Guyancourt
France
Branch of industry: Medical technology, dental products, wound care
Sales category: over € 1 billion
ERP system:
Mathys AG Bettlach
2544 Bettlach
Switzerland
Branch of industry: Medical technology, dental products, wound care
Sales category: 101 to 250 million €
ERP system:
Publicare AG
5452 Oberrohrdorf
Switzerland
Branch of industry: Medical technology, dental products, wound care
Sales category: 51 to 100 million €
ERP system:
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