Quality Management & Audit Expertise
Your Partner for Ensuring Excellent, Compliant Processes in Medical Technology
StingOrg offers you comprehensive support in the areas of quality management and audits for medical devices. Our expertise spans the entire product lifecycle – from development to certification. We not only ensure compliance with the highest quality standards but also create sustainable process efficiency.
The implementation and continuous optimization of an efficient quality management system (QMS) is crucial to the success of a company in the medical technology field. StingOrg supports you strategically and operationally in this process. Our focus is on supporting you in every phase of the product lifecycle – from product development to market launch and beyond.
Our services include the development, monitoring, and improvement of quality management processes according to the standards of ISO 13485, ISO 14971, and other important regulations such as MDR and IVDR. By using proven audit techniques and seamlessly integrating CAPA management (Corrective and Preventive Actions), we not only improve your production and quality processes but also help you identify and minimize risks early on.
Our core competencies include conducting internal and supplier audits, defining non-compliant areas, and developing solutions. With our audit expertise, we help you continuously maintain audit readiness and successfully pass inspections by health authorities. This is ensured through our hands-on approach and regular reporting to your project managers.
Results of our work:
- Completed quality plan
- Optimization of preventive and corrective actions (CAPA)
- Improved status of quality issues
- Audit reports with clear action recommendations
Success factors:
- Improvement of your quality processes
- Reduction in costs and time
- Increased customer satisfaction
- Ensuring compliance with regulatory requirements
Our work does not end with the audit. We also assist you in implementing the results and continuously improving your processes. This ensures a stable foundation for your quality management system, providing long-term relief and preparing you for audits.
Our Services
Comprehensive Quality Management:
Development, optimization, and implementation of the QMS according to ISO standards
Risk-based Audits:
Internal and external audits, mock audits, and continuous audit readiness
CAPA Management:
Efficient management of corrective and preventive actions for problem resolution
Your Benefit
Highest quality assurance:
Compliance with regulatory requirements and sustainable processes
Risk and cost reduction:
Early identification of risks and minimization of potential costs
Efficiency improvement:
Optimization of your production and business processes as well as higher customer satisfaction
Our Promise
Tailored solutions:
Customized consulting and adaptation to the specific requirements of your company
Reliability:
Transparent reporting and timely implementation of improvement measures
Long-term success:
Sustainable implementation of improvement measures to optimize your processes
Malte Stöckert
Our Core Areas: Your Benefits
Quality Management Systems (QMS)
CAPA Management
Our CAPA management ensures not only the correct identification and handling of problems but also the sustainable implementation of preventive measures. This ensures that potential risks are identified and addressed early on, before they become serious problems.
Audit Expertise
Our experienced auditors accompany you from planning to execution and follow-up of audits. With comprehensive know-how, we ensure that all regulatory requirements are met and processes are continuously improved. Our support before, during, and after audits guarantees your audit readiness.
Do you want to move
your business forward?
Let’s take the first steps together!