Safe Placing on the Market  

  of Medical Devices  

ERP for the Medical Technology Industry

In developing market-ready medical devices and placing them on the market, a rapid response to changes in market conditions is crucial for product success. The speed of technological progress sets the pace. In addition, manufacturers must face cost pressures in the healthcare system and the regulatory requirements in their target markets. These are major challenges.

Aligning Processes to the Requirements of Today and Tomorrow

With our process-oriented solution kit GUS-OS Suite, all market requirements can be mapped. This applies both to the company requirements for end-to-end and flexible process control and to the statutory requirements of the Medical Devices Act (MPG) at national and European level:

  • Planning and management of product versions, serial numbers and unique device identifications (UDI)
  • Mapping and control of parallel and outsourced processes
  • Transparent product tracking over the entire product life cycle (post-market surveillance)
  • Mapping of the certification requirements in accordance with ISO13485 and 93/42/EWG
  • Implementation of the specifications of the conformity assessments according to risk classes IIb and III in accordance with the EU Directive 93/42/EEC
  • 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 the ISO requirements and IEC 14971 (risk management)

Partnership Right from the Start

Maintaining a continuous dialog, articulating expectations and goals, exchanging knowledge and experience, listening and active thinking, this is where partnership comes in. Thanks to our extensive know-how of industry and process-related issues, we offer you concrete solution proposals for an efficient and flexible process control during project implementation.


Exploiting existing potentials, becoming better and faster. We support you with a variety of services even after go-live.

Highlights

  • Compliant with MPG, ISO13485 and others
  • Focus on risk classes IIb and III
  • Maps the product life cycle
  • Supply chain qualification
  • Validatable software

Medical Technology References

GUS solutions in use: Take a look at our references from the medical technology sector!

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 in the pharmaceutical sector is very helpful here, as has been confirmed by numerous supplier audits. The GUS-OS Suite is therefore effective, secure and efficient.

Everything at a Glance

Convenient evaluations along the value chain and at the strategic level can be undertaken at any time, even on the go. Thanks to a large number of key performance indicators (KPI) and our integrated business intelligence solution, our customers have their business operations firmly under control from different perspectives!

Other branch solutions:

Getting in Touch

Did we spark your interest? Do you have any further questions? Would you like further information? We look forward to talking to you!