Klavant GmbH is a high technology driven start-up company. As an organisation we drive the design, development, sales, distribution and service of our products. We are committed to comply with applicable regulatory requirements and to build effectiveness into our quality management system. Quality is important to our business and our Quality Management System is our framework in how we work. We continuously measure and improve our performance to meet our customers‘ needs.
Klavant GmbH focuses on clinically relevant applications in which objective intraoperative visualization, assessment and measurement can support surgical decision-making and procedural quality.
Organization & Objectives
Management of organization, along with established quality objectives and defined responsibilities for their fulfilment.
Quality Management System
Establishing, applying, maintaining and continual improvement of effectiveness of Quality Management System according to EN ISO 13485.
Employee Training
Ongoing employee training and education to ensure all staff are equipped with the knowledge to uphold quality standards.
Customer Satisfaction
Continual enhancement of customers‘ satisfaction through quality products and responsive service.
New Technologies
Tracking and applying new technologies.
Legal Compliance
Pursuing legal and standard requirements.
Patient Safety
Ensuring patient safety through rigorous risk management and quality assurance of medical devices.
MDR Compliance
Ensure compliance with Medical Device Regulation (MDR) 2017/745 across all applicable processes.
Device Safety & Servicing
Maintenance and servicing of medical devices and ensuring the highest standards of device safety.
Supplier Management
Qualification and regular audits of suppliers to ensure the supply chain meets our exacting quality standards.
Continuous Improvement Culture
Commitment to increase quality of our products in order to exceed customers‘ expectations
Commitment to quality in every aspect of business processes
Making continuous improvement a part of every day and every job
Ensuring that our policy, processes and work instructions reflect what we actually do
Understanding how our jobs and qualifications fit into the overall flow of work at Klavant GmbH
Continuous improvement of the QMS in design, development, software, and outsourced manufacturing, assembly, packaging, sterilization by regular internal and supplier audits
This policy is part of our Quality Manual. Although the CEO has ultimate responsibility for the Quality Management System, all employees are responsible within their own areas of work for ensuring that quality and regulatory requirements are consistently applied and embedded within everyday work. The CEO is responsible for communicating the Quality Policy to all persons working for or on behalf of the organization and making it available to the public.
