Quality
The drug delivery device solutions manufactured by Nemera are used by millions of patients across the world. Ensuring that our devices are of the highest quality and safe to use is a key priority for us. The customers and individuals using our products trust us and we are committed to bringing them hightest value. Quality is not an obligation but a duty for us. It is an integral part of every aspect of our work, as we believe – quality creates value. At Nemera, we walk the ‘Quality’ talk.
Customer experience
Over the past few decades, we have built a reliable experience for our customers thanks to our robust and sound processes and quality systems. As a result, our customers recognize and trust our quality capabilities leading to long-lasting collaborations. We provide real-time information to our customers on our quality updates. And we don’t stop there – our aim is to achieve excellence in quality across our systems, processes and services through continuous improvement, adherence to evolving quality standards and ultimately making quality a competitive advantage for Nemera.
Quality Culture
We put patients first when it comes to quality as well. We strive to foster a culture of quality that exhibits patient focus and participation, responsibility and awareness of our teams and empowerment of our people. We are doing all this by enhacing our governance, strengthening our internal controls and engaging with our teams through training and information sessions across the company. These guiding principles enable us to think holistically about the quality of our products and services.
Digital
Nemera is at the forefront of digital transformation. We are digitizing our Quality Management Systems (QMS), batch release processes and other supporting systems to drive predictive data analysis and understanding. Furthermore, we are empowering our people in data and digital learning to minimize human errors and data integrity risks. Digitizing quality is strategic to our mission of providing the safest possible products to customers and patients.
Compliance and regulatory standards
Our manufacturing practices are conform to Medical Device Standards and International Regulations such as the MDR, if required GMP certified irrespective of their nature: contract development or life-cycle manufacturing. Good Manufacturing Practices (GMP) outline the minimum standards that drug delivery solution and combination product manufacturers must meet in their production processes. They also play a key role in harmonizing and co-ordinating regulatory expectations. At Nemera, our operations comply to these standards established by external health authorities and international harmonization organizations. Compliance to these standards helps us ensure product safety and quality.
This in turn, ensures patient safety and satisfaction. The following are part of GMP at Nemera: control, quality, safety & effectiveness. Furthermore, we are staying ahead in a rapidly changing world with our Lean approach and methodologies for process simplifications.
Along with GMP conformity, International Standardization Organizations also provide ISO guidelines for drug delivery device solution manufacturers like Nemera. Our Quality Management System (QMS) adheres to the ISO standards in place for medical devices (ISO 13485) , cleanrooms (ISO 14644), primary packaging (ISO 15378), environmental (ISO 14001) and energy management (ISO 50001) to name a few. Based on their location, our manufacturing sites adhere to local health authority regulations.
ISO certifications
Performance
We monitor and continuously improve our quality management to ensure strong real-time performance. It is critical to sustain the performance as it has a direct impact on patient safety and customer experience. It is equally important to nurture sound quality habits as a leading player in the industry.
Supplier Quality Management
Nemera has built trusted relationships, whether new or old, with its suppliers. We make sure our suppliers are aligned with our vision and strategy. The social, ethical and environmental footprint of our devices and services cannot be dissociated from the business practices of our suppliers. International laws and regulations, such as GMP and FDA we comply to, hold us co-accountable for non-compliant behavior in our supply chain. Patients and our customers trust us to act responsibly. Furthermore, we owe quality and safety to our future generations. With this in mind, we work on timely supplier evaluation and governance of all our suppliers.
