Safe medical devices & validated processes
along the entire value chain
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 applies to both the company requirements for end-to-end and flexible process control as well as the requirements of the Medical Devices Act (MPG) and Regulations (EU) 2017/745 and (EU) 2017/746 set by the legislator at 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)
- Complete traceability along the entire value chain based on batch information, serial numbers as well as UDI-PI.
- Mapping of certification requirements Regulatory requirements under Regulations (EU) 2017/745 ("MDR") and (EU) 2017/746("IVDR")ISO13485 and 93/42/EEC.
- Integration into a quality management system according to DIN EN ISO 13485:2021
- Implementation of the requirements of conformity assessments corresponding to risk classes IIb and III according to EU Directive 93/42/EEC Support of the fulfillment of regulatory requirements within the framework of conformity assessment procedures of all risk classes according to Regulation (EU) 2017/745 and (EU) 2017/746 respectively
- Supply chain qualification and monitoring through integrated processes within the framework of quality management according to DIN EN ISO 13485:2021
- Process control along the entire value chain
- End-to-end documentation of all business processes to meet regulatory requirements ISO specifications and IEC 14971 (risk management)
- Support of a risk management system according to DIN EN ISO 14971:2022
ERP for medical technology
It's these functionalities that matter. Watch the short video now!
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.
Highlights
- Compliant with MPG, ISO13485 etc.
- Focused on risk classes IIb and III
- Mapping of the product life cycle
- Supply chain qualification
- Validation capable software
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!
FAQs
You ask - we answer
An ERP software for medical technology is an integrated solution that supports business processes such as production planning, material procurement, quality control, traceability and compliance management. It enables medical technology companies to efficiently manage their resources and business processes.
Challenges in implementing ERP software can include data migration, employee training, and integration with existing systems. These challenges require careful planning, training and support from the ERP vendor.
ERP software optimizes production planning, resource allocation and inventory management, reduces bottlenecks and helps automate production processes, resulting in overall increased efficiency.
The GUS-OS Suite offers the medical technology industry specific advantages such as compliance with strict regulatory requirements. This concerns both the company requirements for end-to-end and flexible process control as well as the requirements of the Medical Devices Act (MPG) set by the legislator at 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)
Yes, ERP software offers extensive functions for quality management, such as the management of inspection records, certificates, deviations and audits. It also enables efficient product documentation and version control.
Yes, the GUS-OS Suite is available as a cloud-based solution, which enables flexible and scalable use. Companies can store their data securely in the cloud and access it from anywhere.
The validation process is one of the most important success factors in medical technology. Accordingly, a good ERP software for medical technology must be able to support this process well. GUS ERP GmbH supports the validation of the business processes mapped in the software by supplying a qualified system in combination with a field-tested methodology. Experience from the pharmaceutical sector is of particular advantage at this point. Thus, the GUS-OS Suite is effective, secure and efficient.
Look & Feel of our ERP software
Curious about the GUS-OS Suite? In our Look & Feel Video you will get a first insight into the heart of our ERP system and gain valuable impressions about an industry-appropriate use.
References ERP Medical Technology
Human is an international supplier of in-vitro diagnostics. The company's goal is to provide a comprehensive range of proven diagnostics of high quality and fair prices.
Dentalpoint AG is the global market leader in the field of metal-free, two-part ceramic implants. The registered brand ZERAMEX® stands for an esthetic and 100% metal-free all-ceramic implant system that addresses a growing patient need.
The internationally active Storz am Mark Group has been manufacturing dental instruments in its dental factory in Germany for over 95 years. The comprehensive stoma range of dental instruments is supplemented by products for instrument reprocessing, such as cleaning, sterilization and storage accessories.
RfB - the Reference Institute for Bioanalytics, is one of the two German proficiency testing organizations officially commissioned by the German Medical Association to carry out proficiency testing for external quality control. The offer includes over 100 different proficiency testing systems in the entire field of laboratory medicine.
Dr. Caroline Stobe
Foundation for Pathobiochemistry and Molecular Diagnostics
Case Studies ERP Medical Technology
Further industry solutions
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