Flexible Response to the Markets
ERP for MedTech
In developing market-ready medical devices and placing them on the market a swift response to changes in market conditions is crucial for product success. The speed of technological progress sets the pace. Furthermore, manufacturers must deal with cost pressures in the healthcare system and regulatory requirements in their target markets. These are major challenges.
Aligning Processes to Today’s and Tomorrow’s Requirements
With our process-oriented solution kit the GUS-OS Suite all market requirements can be mapped. That goes both for corporate requirements of end-to-end and flexible process control and for the statutory requirements of the Medical Devices Act (MPG) at the national and the European level:
- Planning and administration of product versions, serial numbers, and unique device identifications (UDIs)
- Mapping and control of parallel and outsourced processes
- Transparent product tracking across the entire product life cycle (post-market surveillance)
- Mapping of certification requirements according to ISO 13485 and 93/42/EECImplementation of the conformity assessment provisions in accordance with the EU Directive 93/42/EEC’s risk classes IIb and III
- Supply chain qualification and monitoring by means of integrated quality management
- Process control along the entire value chain
- End-to-end documentation of all business processes to fulfill ISO and IEC 14971 (Risk Management) provisions
Validation a Matter of Course
In validating the business processes mapped in the software GUS provides support by supplying a qualified system combined with a methodology that has been proven in practice. Our experience in the pharmaceuticals sector is very helpful here, as has been confirmed to us by a large number of supplier audits. The GUS-OS Suite is thus effective, safe, and efficient.
At a Glance
Easy-to-use evaluations along the value chain and at the strategic level can be undertaken at any time, including from on the move. By means of a large number of key performance indicators (KPIs) and our integrated business intelligence solution, our customers have their business operations firmly under control from a variety of perspectives.
- Conforms to MPG, ISO 13485, et al.
- Focus on risk classes IIb and III
- Maps the product life cycle
- Supply chain qualification
- Validatable software
Cooperation from the Very Beginning
Continuously engage in dialogue, express expectations and goals, exchange knowledge and expertise, listen and think actively. Thanks to our comprehensive expertise in industry and process-related issues we are able to out forward real and concrete solutions for an effective and flexible workflow management during the implementation project.
Efficiency and flexibility are company properties to gain a competitive edge. Exploit existing potential. Become faster and better. At this we assist you after Go-Life with a variety of services.