Initiation
We start by allocating you a dedicated medical writing / regulatory team of subject matter experts with clinical experience in your device's field of use.
Summary of Safety and Clinical Performance (SSCP) for EU market access
SSCP writing & readability testing from an international team of clinical & regulatory experts
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Need consulting support or a quote? Get in touch with us today
100% success rate for SSCP submissions under the EU MDR
Our team combines medical device regulatory specialists with clinicians who are experts in writing for professional and lay audiences.
- Complete EU MDR & MDCG compliant SSCP service
- SSCP writing & readability testing for EU market access
- Fully insured ISO & TOPRA-registered consultants
- Transparent quotes with fixed pricing & guaranteed timelines
- Scalable capacity servicing a worldwide client base from start-ups to multinationals
A complete SSCP service for implantable & class III medical devices
Mantra Systems takes pride in its proven SSCP framework with 100% success rate for submissions under the MDR.
- New SSCP reports and readability tests
- Updates to previous SSCPs & readability reports
- Review of existing SSCPs & input documents (e.g. CERs, PSURs)
- Literature reviews to optimise Clinical Evaluation Reports
- Responding to Non-Conformity Reports (NCRs)
- Working with tight deadlines & re-submissions
Our guarantee to you
A team of highly experienced regulatory professionals who will ensure compliance of your device while providing a seamless & transparent collaboration experience.
- Tailored & quick quote with set prices & no hidden costs
- Carefully selected project team with clinical experience matched against the field of your device
- Fixed timelines & commitment to meet deadlines
- Weekly updates on project progress with full transparency
- No final payments until 100% client satisfaction
- Ongoing support after SSCP submission to Notified Body with no additional cost
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Our Clients say
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Please thank all of your team for their brilliant efforts. Your standard of service, response time, and rigour were outstanding and I would strongly recommend you to any other potential client.
ABQuality Advisor Manufacturer, UK
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A comprehensive, detailed and highly professional service.
BGRegulatory Manager Manufacturer, UK
Our SSCP process
We have developed a successful process to ensure the production of high quality EU MDR compliant SSCPs & readability reports.
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Input documents review
The team will conduct an extensive review of all relevant input documents (e.g. CERs, Risk Management documents, PSURs, & IFUs) shared through a confidential & secure IT system.
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Framework generation
The team will produce an SSCP report framework appropriate to the subject device including, where relevant, a patient-specific section and readability protocol.
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SSCP writing
Lead medical writers will produce a 9-section SSCP along with patient specific SSCP and readability test protocol (if relevant) using a proven structure, collating device specific information from the input documents.
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Client draft review
The draft will be submitted for review at your pace and capacity. A review call is then held, feedback collated and adjustments made.
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Start readbility test
After your approval, the readability test starts and the results are analysed as they come in.
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Readability optimisation
Following the readability test, if any adjustments become necessary we will make recommendations for readability optimisation.
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Finalised reports
The result is an MDR-compliant SSCP along with readability test report (if relevant) meeting all regulatory requirements and ready for Notified Body review and EUDAMED submission.
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Post-submission
We then provide Notified Body review support, standing 100% by our work and giving you complete peace of mind.
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Outcome
Our goal is full approval of your devices. Get in touch with our team for a free, confidential & no obligation discussion.
Clinical experts & TOPRA registered professionals
Mantra Systems has a dynamic team of subject matter experts with extensive experience in the SSCP process.
Our active clinicians will critically evaluate and summarise the safety and performance of your medical device, with specific insight into how your device impacts patient care. Their clinical expertise will address the challenge of writing SSCPs for both clinicians and lay persons. Having this unique international team also means we can successfully run multiple projects of any size and complexity.
We match each project to subject matter experts who work within the clinical field of the device under evaluation, providing the perfect foundation for a medical device SSCP.
We have over 50 subject matter experts based in the UK, Europe, USA, Canada, South Africa, and India. Their specialities include:
- Anaesthetics / intensive care
- Cosmetic surgery
- Elderly care
- Emergency medicine
- General practice / family physician
- Internal medicine
- Maxillofacial surgery
- Obstetrics / gynaecology & neonatal care
- Ophthalmology
- Orthopaedics
- Rheumatology
- Upper & lower GI surgery
- And many more…
Our Clients say
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All aspects of communication from Mantra Systems have been excellent from initial contact to the conclusion of the work. There was excellent communication during the projects, included reviews and discussions helping to maintain the momentum and provide the required outcomes.
DSRegulatory & QA Manager Manufacturer, UK
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Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.
KWChief Executive Officer SaMD Company, UK
SSCP in context
SSCP is an entirely new requirement under the EU MDR that must be produced in relation to implantable and class III medical devices, except custom-made or investigational devices.
The main objective of the SSCP is to summarise clinical data and other information concerning the safety and clinical effectiveness of the medical device and to make it accessible to the general public in an appropriate form. It is written specifically for medical device end users, including both healthcare professionals and, if applicable, patients.
Since SSCP targets both audiences with varying degrees of expertise, it demands excellent technical writing abilities. To ensure that the patient-targeted SSCP is suitable for its intended audience, it is necessary to conduct a readability test.
The challenge
Being an entirely new requirement under the MDR, SSCPs are a source of potential confusion and uncertainty amongst medical device manufacturers and regulators alike.
Furthermore, because an SSCP may need to include sections for different audiences (laypersons and clinicians), uncertainty over content is compounded by questions over styling and use of language.
SSCP success relies on the skill of the medical writer, implementation of an appropriate framework and high quality input documents.
Why a well-written CER is vital to the SSCP process
The information presented in the SSCP should be sourced from the device's technical documents, known as input documents. A well-written CER is the kernel of a successful SSCP.
Requirements include:
- Developing a well-structured CER structure/framework
- Performing an extensive & systematic literature review for SOTA & subject device
- Conducting an objective appraisal of identified evidence
- Segregating relevant safety & performance benchmarks from the appraisals
- Conducting an analysis comparing evidence on subject device with benchmarks
- Carefully formulating conclusions & arguments derived from the subject device's clinical evidence
The right strategy demands thorough knowledge of the clinical field of the subject device and expertise in working with clinical evidence.
Our team of skilled medical writers have years of clinical and regulatory experience along with deep knowledge of the EU MDR.
Get in touch for a free and open chat to see how we can support you with your compliance requirements.
Are you looking for…
- SSCP consulting support?
- A quote for our services?
- Help understanding your options?
Whatever you need, contact us today for a free & confidential discussion.
Our Clients say
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Regular meetings were implemented to ensure understanding of both parties and to discuss and address any findings within individual reports. We would engage the services again in the future should the need for further support arise.
PWHead of Clinical Governance & Regulatory Affairs Manufacturer, UK
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It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.
JFChief Executive Officer SaMD Company, Denmark