Safe placing on the market
of medical devices
ERP for medical technology
In the development and marketing of market-ready medical products, rapid response to changing market conditions is crucial to product success. The speed of technological progress sets the pace. In addition, manufacturers must confront cost pressures in the healthcare system and regulatory requirements in target markets. The challenges are great.
Aligning processes with the requirements of today and tomorrow
With our process-oriented modular solution GUS-OS Suite, all market requirements can be mapped. This concerns both the company requirements for a continuous and flexible process control as well as the requirements of the Medical Devices Act (MPG) set by the legislator on a national and European level:
- Planning and management of article variants, serial numbers and Unique Device Identifications (UDI)
- Mapping and control of parallel and outsourced processes
- Transparent product tracking throughout the entire product life cycle (post-market surveillance)
- Mapping of certification requirements according to ISO13485 and 93/42/EEC
- Implementation of the specifications of the conformity assessments according to the risk classes IIb and III according to the EU Directive 93/42/EEC
- Supply chain qualification and monitoring through integrated quality management
- Process control along the entire value chain
- Consistent documentation of all business processes to comply with ISO requirements and IEC 14971 (risk management)
Partnership from the start
Maintaining a continuous dialog, articulating expectations and goals, exchanging knowledge and experience, listening and thinking along. For us, this is where partnership comes in. With our extensive industry and process know-how, we offer you concrete solution proposals for efficient and flexible process control during project implementation.
Exploit existing potential. Become better and faster. We also support you after the live start with a wide range of services.
- Compliant with MPG, ISO13485 etc.
- Focused on risk classes IIb and III
- Mapping of the product life cycle
- Supply chain qualification
- Validation capable software
References medical technology
The GUS solutions in use: Take a look at our references from medical technology!
Validation as a matter of course
In the validation of the business processes mapped in the software, GUS provides support through the delivery of a qualified system in combination with a field-tested methodology. Our experience from the pharmaceutical sector is very helpful here, which we have had confirmed by a large number of supplier audits. Thus, the GUS-OS Suite is effective, secure and efficient.
Everything at a glance
Convenient evaluations along the value chain and at the strategic level are possible at any time. Even on the road. Using a variety of key performance indicators (KPI) and our integrated business intelligence solution, our customers have a firm grip on what is happening in their company from different perspectives!
Other industry solutions:
Get into conversation
Is your interest aroused? Do you still have questions? Do you need more information? Are you looking for a conversation? We are looking forward to the dialog with you!