Our clinical and post-market practice is led by Amie Smirthwaite, PhD, former BSI global head of clinical compliance and contributor to both MDCG 2019-9 (SSCP guidance) and MEDDEV 2.4/1 Rev 4 (Clinical Evaluation guidance). Amie leads a team of clinical regulatory affairs experts who live and breath clinical evaluations for MDR and performance evaluations for IVDR.
We've created hundreds of CERs and PERs under the new regulations and can ensure the information is summarized appropriately to enable creation of a concise SSCP/SSP. We know what should be in them and what notified bodies expect.
We provide all the resources—people, processes, and technology—to create exceptional documentation, including SSCPs and SSPs that meet notified body expectations and reduce the burden on your team.
The goal of the SSCP/SSP is to enhance transparency and provide adequate public access to summarized data on safety and performance to intended users. However, this public-facing document is generating much anxiety for manufacturers who fear how the market will perceive the data and benchmark it against competitors.
Our experienced team knows how to provide enough detail to meet requirements and notified body expectations without giving away confidential information.
RQM+ provides SME and former notified body review to not just your SSCP/SSP, but to the whole package - technical documentation, CER/PER, PMCF/PMPF, and PSURs - to ensure you're telling a cohesive and consistent story to the notified body. The team will support you with responses to notified body questions and any updates needed, as well as annual updates and submissions. Maintaining the lifecycle of the SSCP/SSP and all of the elements that feed it - CER/PER, IFU, Risk, PMS - can feel overwhelming and impossible to keep up with. With RQM+ as your partner, you won't have to worry about being ready for the next update or missing a deadline.....we'll do the work and ensure you stay on track.
Our team of clinical regulatory experts is providing SSCPs and SSPs to clients across the industry and across notified bodies. If you have a challenge, it's likely we've already encountered it and developed a solution. Here are a few common challenges we're seeing:
AlignmentAligning SSCPs and CERs for medical devices and SSPs and PERs for IVDs can be challenging. In addition, it's difficult to update these documents throughout the lifecycle of the device. Our comprehensive solutions can help you solve these problems.
Most manufactures are uncertain about how to present the residual risks in the SSCP/SSP. Our notified body experts were involved in writing the guidance and have conducted many SSCP reviews. We have the answers and are here to help.
It's not always clear how to confirm the readability of the patient section. We have experience in doing readability tests in an efficient manner that will help you validate the readability of your SSCP/SSP.
Updates & Maintenance
Updating these documents on an annual basis will be difficult. We'll optimize your process and create a maintenance plan to ensure all inputs and outputs align and maintenance can be as efficient as possible. If it still requires more resources than you have, we'll be an extension of your team to get it done.
SSCPs/SSPs are just a piece of the story.
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