The IVDR (In-Vitro Diagnostic Regulation) is a new set of regulations set forth by the European Union (EU) in 2017 to regulate medical devices and in-vitro diagnostic devices. The purpose of the IVDR is to improve patient safety by ensuring that all medical devices, including in-vitro diagnostic devices, are designed, manufactured, and marketed to meet the highest safety and quality standards.
Read this White Paper to Understand the Challenges of the IVDR:
- The biggest challenge facing the medical device and in-vitro diagnostic industries is the transition to the new IVDR requirements.
- The IVDR requires all medical devices, including in-vitro diagnostic devices, to be reclassified, re-evaluated, and re-certified. This can be a time-consuming and expensive process for manufacturers.
- The IVDR introduces new requirements for clinical evaluations and performance studies, which can be challenging for some manufacturers, especially small and medium-sized enterprises (SMEs).
- The IVDR requires manufacturers to establish and maintain a robust post-market surveillance system, which can be difficult for some companies, particularly those with limited resources.
Journey of IVDR:
- The IVDR requires all medical devices, including in-vitro diagnostic devices, to be classified into four classes, based on their level of risk.
- Manufacturers must comply with the IVDR requirements by following a comprehensive and rigorous assessment process, including clinical evaluations and performance studies.
- The IVDR requires that all in-vitro diagnostic devices must be CE marked, indicating that they meet the essential requirements of the regulation.
- The IVDR establishes a new EU-wide system for the vigilance and market surveillance of medical devices, including in-vitro diagnostic devices, to ensure their ongoing safety and performance.
DOWNLOAD THE WHITEPAPER
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“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”