The goal of cross-functional integration is to ensure that overall safety and performance are aligned with the intended use, instructions for use, claims, technical documentation, and risk management. With multiple departments that have their own priorities and systems, we know how challenging it can be to get your internal systems to align.
Quality system updates to meet MDR and IVDR requirements—especially the integration of risk, PMS, and clinical elements—can feel overwhelming and impossible to get right the first time. Our dedicated project managers who focus only on QA/RA projects will implement an efficient project timeline and smooth transition, putting your mind at ease by ensuring all impacted departments are working in alignment.
The seasoned professionals at RQM+ know how to ensure the necessary linkages between technical documentation, clinical evaluation documents, PMS documents, and risk management documents in order to improve alignment and increase efficiency.
We will review your existing systems to identify areas for improvement and develop optimized procedures that set the foundation for compliance. Optimization ensures that the same data is not being generated or reported in different ways across functions, which leads to wasting precious resource time and potential confusion in audits. Our collective knowledge and best practices will be incorporated into a system that is customized for your business.
With thousands of projects under our collective belts, we have truly seen it all. This has allowed us to develop and optimize tools and best practices that help you efficiently and consistently achieve compliance. We know our approach is effective because the results have been validated by notified body client audits.
RQM+ is at the forefront of regulatory and quality compliance.
With decades of experience and deep industry connections with various notified bodies and health organizations worldwide, RQM+ is a leading source for industry insights and best practices.
The video FAQ provides a helpful graphic along with our subject matter experts describing the cross-functional integration of the QMS and how the data flows between PMS, PMCF, and clinical activities, Where do we start? It looks straight forward - you have a new product with claims and a risk analysis, flowing into a CER, which flows into a PMCF plan and then data from PMS and PMCF activities flow back to the risk analysis which gets updated. However, rather than being a smooth wheel like what was just described, it's more like a wheel with eddies in it, or cycles within a cycle, and that's expected. The important thing is having a procedure and document control system that shows how you're managing all of these inputs and changes.
It's not feasible to identify and list all risks, but knowing where to draw the line can be difficult. Per the GSPRs, every residual risk should be listed. The notified bodies are using a pragmatic approach in assessing whether all of the important risks have been listed, but the interpretation can vary by notified body reviewer. In this video FAQ, our former notified body reps discuss factors they considered and a couple examples.
At the end of the process, the NB issues a certificate, but it's the manufacturer who signs the DOC and it is the manufacturer's responsibility to define what is appropriate. The manufacturer knows the device and intended population the best, but the information must be clearly documented in the risk management process for review by the NB. The NB may raise a gap identified in the review process and push to add a residual risk, and that will need to be resolved with the manufacturer during the Q&A process.
One factor in ensuring your risk assessment is comprehensive is to utilize a cross functional team to appropriately identify and agree on residual risks. It cannot be done effectively with just a risk manager or just a clinical person - it takes a team.
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