Our kick-off webinar will introduce you to Platomics, our IVDReady Program, our partners, and IVD Assistant, our platform for compliance.
The first thing your lab needs is a strategy for documenting workflows, whether you’ve got 50 or 250 in-house tests. This webinar will outline several possible approaches.
The next step is formulating the intended purpose for your in-house tests. From here this webinar will also cover documenting qualification as a medical device and risk classification under IVDR.
This webinar will outline Platomics’ regulatory knowledge base that supports labs in understanding what exactly the IVDR requires of them.
Here we’ll show how our Workflow Studio quickly allows your lab to create compliant workflows by integrating manufacturers’ components plus the required documentation from the manufacturer.
GSPRs are challenging, and therein lies the beauty of established standards: they are state-of-the-art and as such can reliably fulfill the GSPRs. Find out what your lab needs to do and how best to get it done.
Labs will need to have a robust risk management process in place to meet the requirements and ensure safety and reliability for patients. This webinar will provide orientation.
We’ll explain how to fulfill both IVDR and ISO 15189 requirements regarding verification and validation, and how there is no “one size fits all” on this issue.
We’ll take you through various aspects of product excellence required by IVDR, from instructions for use to labeling, SOPs and documenting the design and manufacturing of your in-house tests and components.
Perhaps the most daunting aspect of the IVDR for labs are the new requirements for clinical use surveillance. We’ll explain what active vigilance throughout the life cycle of your in-house tests means for your lab.
Our final webinar will offer an outlook on important aspects for remaining IVDR compliant, including what is coming in the final phase of implementation in 2028.