Expertise.
Quality
management.
Customized quality management solutions for efficient and compliant processes.
Efficient?
Are your quality processes optimally tailored to the specific requirements of your industry?
Are you sure?
Do you ensure compliance with all relevant regulations such as GMP and ISO 13485 for maximum product safety?
Flexible?
Do your quality management solutions adapt seamlessly to your company's individual processes?
Discover hidden potential in your quality management.
Quality management and compliance in medical technology and pharmaceuticals.
Meet the highest quality standards and always remain compliant with the regulatory requirements of your industry.
Our Quality Assurance (QA) Consulting supports you in implementing efficient and compliant quality management processes. We help you to meet the requirements of GMP, ISO 13485 and other relevant standards.
We support you with:
- Implementation of GMP and ISO-compliant quality management systems
- Preparation for audits and official inspections
- Process optimization and risk management
- Education and training of your employees on quality standards
Our quality management solutions at a glance.
Our comprehensive QA services help you to meet regulatory requirements and ensure your product quality.
Audit Preparation & Compliance.
- Preparation for audits by national and international authorities
- Identification of compliance risks and optimization of audit capability
- Support during official inspections
Risk management & process optimization.
- Carrying out risk analyses to identify potential vulnerabilities
- Implementation of process optimizations to increase efficiency
- Introduction of control measures to minimize risk
Education & Training.
- Training employees on current quality standards and best practices
- Conducting training courses on compliance with GMP, ISO 13485 and other standards
- Establishment of a continuous improvement process in the company
Our success stories in quality management.
Find out how we have helped companies in the medical technology and pharmaceutical industries to achieve their quality goals.
Optimization of quality processes in a pharmaceutical company
Increasing product quality in a medical technology company
Challenge.
A medical technology company was faced with the challenge of reducing quality defects in production and achieving ISO 13485 certification.
Measures.
- Analysis of production processes and identification of weak points.
- Implementation of a quality management system in accordance with ISO 13485.
- Training employees on quality standards and best practices.
Results.
- Reduction of production errors by 40 %.
- Successful ISO 13485 certification at the first audit.
- Increased customer satisfaction through improved product quality.
Success.
The company was able to tap into new market segments and significantly increase its competitiveness.
Take the next step towards excellent quality processes.
Quality management - your solution for the highest standards.
With our comprehensive quality management service portfolio, we accompany you on the path to the highest quality and compliance. We understand the specific challenges in medical technology and pharmaceuticals and offer tailor-made solutions that optimize your processes and drive your company forward.
We support you in complying with international standards such as GMP, ISO 13485, ISO 9001 and other relevant standards. Our expertise enables you to safely fulfill regulatory requirements and thus ensure the quality of your products and services. In addition, we prepare you comprehensively for official inspections and customer audits by carrying out mock audits and preparing gap analyses. We also help you to develop and optimize your quality management documentation to ensure maximum transparency and traceability.
By analyzing and optimizing your quality processes, we achieve efficiency gains and reduce throughput times and costs. We introduce digital quality solutions and modern technologies that enable effective data management and real-time monitoring of your processes. By applying lean management principles, we support you in eliminating waste and sustainably improving the performance of your processes.
Our approach to risk management includes the systematic identification and assessment of quality risks in your processes and products. We develop and implement effective risk reduction measures using methods such as FMEA and HACCP. By establishing key performance indicators and monitoring systems, we enable continuous monitoring so that you can identify deviations at an early stage and react accordingly.
We attach great importance to the qualification of your employees and offer training courses and workshops on quality standards, regulatory requirements and best practices. As part of change management, we support you in change processes to ensure the successful implementation of new quality strategies. We also promote company-wide quality awareness in order to establish sustainable improvement and a culture of quality.
Quality along your supply chain is crucial to the success of your business. We support you in evaluating and developing your suppliers to ensure compliance with quality standards. We also help you to draw up and implement quality agreements with partners and suppliers. By conducting audits of suppliers and service providers, we ensure compliance and contribute to the stability of your supply chain.
