Essential Milestone for Quality and Collaboration
We are thrilled to announce that we have achieved ISO 13485 certification for D2F™ pre-fillable glass syringes produced in our Münnerstadt facility in Germany. This important milestone emphasizes our strong commitment to achieving the highest quality standards for our pharma packaging activities. Furthermore, this certification is extremely important as it brings a host of benefits to our valued customers, ensuring a more seamless collaboration as well as an enhanced customer experience.
Speaking the Same Language
With ISO 13485 certification, we align our quality management system with the international standard used by our customers. This common framework allows us to speak the same language, simplifying communication and fostering mutual understanding.
Facilitating quality-to-quality interactions
Our certification ensures that customers are familiar with the applicable standard when they visit and audit us. By facilitating quality-to-quality interactions, we create an environment where our customers can confidently engage with our processes, confirming that they meet the required standards.
Bridging Quality Systems
ISO 13485 certification bridges our quality system with those of our customers, providing continuity of compliance throughout the value chain. This alignment ensures that our products and services seamlessly integrate with our customers’ requirements, enhancing overall efficiency and reliability.
Supporting Global Registration Processes
For customers operating in countries that classify pre-filled syringes (PFS) as medical devices, such as Japan and South Korea, our certification simplifies the registration process. By adhering to ISO 13485 standards, we facilitate smoother and faster regulatory approvals, helping our customers bring their products to market more efficiently.
Commitment to Continuous Improvement
Our journey doesn’t stop with certification. We are dedicated to continuously upgrading our system with a process approach, supported by robust risk management tools. This ongoing commitment ensures that we not only meet but exceed industry standards, providing our customers with the highest level of quality and safety.
We are excited about the opportunities this certification brings and look forward to continuing our partnership with you, our valued customers, as we strive for excellence in every aspect of our operations.
