An SSCP/SSP starts with a good clinical evaluation.

"Any deficiencies in the CER are likely to be reflected in the SSCP."

- Jai Kutty, former NB leader

  • RQM+ Process and People

    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. 

  • SSCP and SSP Creation

    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. 

  • SSCP/SSP Validation

    With the requirements being so new, manufacturers often don't know what notified bodies expect to see for evidence of validation, and in particular, how to perform user readability test if needed. RQM+ has conducted many validation studies, received notified body feedback, and continually refines and updates our processes based upon our evolving understanding of this requirement. Our clinical practice includes former notified body leaders who joined RQM+ in recent months, and have reviewed many SSCPs and SSPs.
  • Submission and Maintenance

    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.

  • Solutions to Challenges

    Our team of clinical regulatory experts are 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:

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    Alignment

    Aligning 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.
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    Risk

    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.

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    Validation

    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.

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    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.

    Learn about the Performance Evaluation Solution

    Learn about Clinical Evaluation Solutions

    Learn about Quality System Integration

    Learn about PSURs

    SSCP and SSP FAQs

    What was the thought process behind MDCG 2019-9, in the words of Amie Smirthwaite?

    How much detail should you include in the SSCP?

    When do you need an SSCP for both the lay person and the medical professional?

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

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