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Do you need a short report for your class III product according to the current regulations?
Has the Notified Body revealed any deficiencies concerning your documentation?
Do you want to outsource a regular annual update of the SSCP?
Are you looking for regulatory support concerning the summary for your implant?
Do you need additional human resources?
Are you looking for external know-how and independent expertise?
We are happy to work in our own SSCP templates. However, to ensure consistency with your QM system, we recommend using your templates and considering all relevant interfaces with your SOPs.
We have developed our templates based on the requirements of Regulation (EU) 2017/745. Based on our experience with the preparation of SSCPs, we have adapted and further developed them to the recommendations of the MDCG-2019-9 guideline.
Whether you need complete solutions from a single source or support with individual tasks – we tailor our SSCP services to your individual needs and processes.
Together we define the strategic approach for the establishment of the SSCP and agree on a time frame. In particular, process interfaces and the relevant deadlines that must be met are taken into account. In this phase, we will exchange all necessary information.
We establish the SSCP for medical professionals based on the technical documentation provided by you. We take into account the requirements of the MDCG 2019-9 guideline and, in particular, other guidelines on stylistic recommendations. This is followed by a review of the draft by your team.
For medical devices that are not exclusively intended for use by medical professionals or when patients will receive an implantation card for implants, we also create an SSCP for patients. In this case a review by medical professionals and a “readability test” by laypersons will take place.
We coordinate the necessary translations into the various languages of the member states in which your medical device is to be placed on the market. In doing so, we cooperate with translation agencies of your choice or select a suitable company for you.
The initial SSCP must be validated by your Notified Body. If you wish, we can support you in preparing the documentation and carry out a consistency check with your technical documentation. We also help you to coordinate the activities in case of necessary updates.
At this point, unfortunately, we can not help. But you have no work with it either. Uploading the SSCP in EUDAMED is the task of the Notified Body. However, we will work with you to ensure that the deadlines are met and that your label (label, IFU) contains the appropriate references to the SSCP in EUDAMED.
The nesting of technical documentation content, the disclosure of new data as well as recertification activities require a regular review of the SSCP and if necessary an update. We will support your team in all matters and help you stay on top of things.
The SSCP must be reviewed annually. If there is new relevant data on safety and performance, then we will help you to incorporate it.
We thoroughly review your SSCP documentation. Depending on your individual needs, we either work with your templates or use our tried and trusted ones. .