With the GUS-OS Suite, GUS ERP GmbH offers a web-based ERP business solution for medical technology that includes all industry functionalities and fulfills regulatory requirements.
When developing and launching market-ready medical devices, reacting quickly to changing market conditions is crucial for product success. The speed of technological progress sets the pace. In addition, manufacturers must face up to the cost pressure in the healthcare system and the regulatory requirements in the target markets. The challenges are great.
Shaping the supply chain
With our process-oriented GUS-OS Suite solution kit, all market requirements can be mapped. This applies both to companies' requirements for end-to-end and flexible process control, as well as to the requirements set by legislators at national and European level.
National and European legislators in the Medical Devices Act (MPG):
- Planning and management of article variants, serial numbers and unique device identifications
- Mapping and control of parallel and outsourced processes
- Transparent product tracking over the entire product life cycle
(post-market surveillance)
- Mapping of certification requirements in accordance with ISO13485 and 93/42/EEC
- Implementation of the conformity assessment requirements in accordance with risk classes
IIb and III according to EU Directive 93/42/EEC
- Supply chain qualification and monitoring through integrated quality management
- Process control along the entire value chain
- Continuous documentation of all business processes to ensure compliance with ISO specifications and IEC 14971 (risk management)
Validation as a matter of course
GUS supports the validation of the business processes mapped in the software by supplying a qualified system in combination with a tried-and-tested methodology. Our experience from the pharmaceutical sector is very helpful here, which we have had confirmed by a large number of supplier audits. The GUS-OS Suite is therefore ideally suited to the requirements of the medical technology sector and works safely and efficiently.
Everything at a glance
Convenient evaluations along the value chain and at a strategic level
are possible at any time. Even on the move. A wide range of key performance indicators (KPIs) and our integrated business intelligence solution give our customers a firm grip on their business from a variety of perspectives!
