POST-MARKET SERVICES
Continuous PMS, PMCF, PMPF, PSUR, and SSCP support that keeps your evidence lifecycle organised, traceable, and audit-ready.
Maintaining
over 40
Clinical Evaluation & Performance Evaluation files year-on-year
25+maintenance audits passed and counting.
Zero document failures.
Approval does not end your regulatory obligations; in many ways, it begins them.
Under EU MDR and IVDR, manufacturers must continuously generate post-market evidence, revisit benefit-risk conclusions, and keep every layer of their technical documentation in step with what their surveillance systems are finding. The regulations are designed that way deliberately. The assumption is that a device's safety and performance profile will evolve, and that the evidence base must evolve with it.
For most regulatory teams, that creates a very specific kind of pressure: recurring update cycles, manual literature monitoring, and the persistent concern that something important has slipped through before the next Notified Body review arrives.
SciMed helps manufacturers manage that pressure through a structured, sustainable evidence lifecycle: one where Clinical and Performance Evaluation maintenance, PMS, PMCF/PMPF, PSUR, and SSCP outputs remain connected, current, and defensible throughout the cycle.
Why Post-Market Compliance is so Demanding
The reality of MDR and IVDR lifecycle obligations:
The post-market framework under MDR and IVDR is not a checklist you complete. It is a continuous operating requirement.
Manufacturers must maintain an active Post-Market Surveillance system, conduct Post-Market Clinical Follow-Up or Post-Market Performance Follow-Up, produce Periodic Safety Update Reports, keep their Summary of Safety and Clinical Performance current, and ensure their clinical or performance evaluation reports reflect the latest available evidence.
Each of these obligations exists on its own update cycle. Each feeds into the others. And each one, if allowed to drift out of alignment, creates a gap that reviewers will find.
In practice, that creates three pressures that regulatory teams report again and again:
Audit Anxiety
The fear that a documentation gap; a PSUR not fully aligned with the CER, or a PMCF plan that hasn't been updated since the last major guidance change, will surface during a Notified Body review. Not because the team hasn't been working hard, but because the sheer volume of interconnected obligations makes it difficult to see the whole picture at once.
Evidence Integration Challenges
Post-market outputs frequently exist in isolation. PMS data sits in one place. The clinical evaluation lives in another. Risk management files are updated separately. When those threads aren't deliberately connected, the documentation tells inconsistent stories and that inconsistency is exactly what reviewers are trained to look for.
Continuous Update Workload
Annual or biennial update cycles, combined with ongoing literature monitoring and shifting regulatory guidance, create a workload that rarely has a natural pause point. For lean regulatory teams, it can feel like the updates never quite finish before the next cycle begins.
These are not failures of competence. They are structural features of a compliance framework that demands continuous attention, and they are exactly what SciMed is built to manage.
SciMed’s Post-Market Services
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Keeping clinical evidence aligned with the latest medical knowledge is an ongoing responsibility, not a one-time task.
SciMed provides structured, continuous monitoring of published literature, evolving regulatory guidance, and emerging safety signals relevant to your device. By maintaining a clear and current picture of the state of the art, we ensure that your evidence base remains defensible so there are no unwelcome surprises when annual evidence reviews come around.
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A well-designed PMS system is the backbone of compliant post-market activity under MDR and IVDR.
SciMed designs and maintains structured surveillance systems tailored to your device and quality management framework; covering PMS plan development, QMS integration, ongoing surveillance monitoring, vigilance analysis, and data trend review.
The result is a living surveillance system that continuously generates actionable evidence, feeding directly into your regulatory documentation and supporting ongoing compliance.
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SClinical evidence cannot stand still. It must evolve alongside real-world device use throughout the entire product lifecycle.
SciMed supports manufacturers at every stage of the PMCF process, from developing and maintaining PMCF plans and supporting PMCF studies, through to producing evaluation reports and integrating findings into Clinical Evaluation Report updates. This ensures your clinical evidence base remains current and reflective of actual patient outcomes, rather than relying solely on pre-market data.
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For manufacturers of in vitro diagnostic devices, demonstrating ongoing performance is a core requirement under IVDR, and PMPF is the mechanism through which that evidence is gathered and reported.
SciMed provides end-to-end PMPF support, including plan development, structured reporting, and integration into performance evaluation reports. This gives IVD manufacturers a structured process for maintaining the performance evidence needed to support device claims and meet Notified Body expectations over time.
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A PSUR is more than a compliance deliverable. It is a structured argument that your device's benefit-risk profile remains sound, and it will be read critically.
SciMed prepares PSURs in accordance with MDCG guidance, drawing on systematic analysis of PMS data, updated benefit-risk assessments, and careful alignment with your Clinical Evaluation Report and risk files. The outcome is a coherent, well-evidenced document that presents your safety profile clearly and is designed to withstand Notified Body scrutiny with minimal avoidable follow-up.
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For Class III and implantable devices, the SSCP is a public-facing document read by clinicians and patients, which means accuracy and clarity are both non-negotiable.
SciMed ensures your SSCP is fully aligned with your clinical evaluation conclusions, reflects the latest PMS and PMCF evidence, and is written in language that is meaningful to its intended audience. A well-crafted SSCP not only meets the regulatory requirement but also supports confidence in your device among its intended audiences.
SciMed’s services are for you if…
You'll likely recognise yourself here
Post-market compliance rarely feels urgent until suddenly it does. If any of the situations below sound familiar, SciMed's post-market services are probably worth a conversation.
You're preparing for a Notified Body surveillance audit…
…and you want confidence that your PMS system, PSURs, and clinical evidence updates are genuinely aligned; not just individually complete, but traceable as a connected whole.
Your PMS outputs aren't clearly feeding into your CER/PER or risk files…
…and you're aware that reviewers may question the traceability of your post-market evidence if the links between surveillance data and clinical conclusions aren't explicit.
Your team is approaching a PSUR or SSCP update deadline…
…and you need experienced support translating surveillance data into clear, regulator-ready documentation; without starting from scratch or cutting corners to meet the timeline.
Your PMCF or PMPF activities feel reactive rather than planned…
…and you'd like a structured programme that produces meaningful lifecycle evidence as a matter of course, rather than a last-minute effort before the next review cycle.
Your regulatory team is managing post-market obligations alongside everything else…
…and maintaining PMS, literature monitoring, and evidence updates has become difficult to sustain at the standard your documentation actually requires.
You want a long-term partner to maintain post-market compliance…
…not a consultancy that delivers a single report, closes the file, and leaves your team to manage the next update cycle alone.
If you're looking for someone to quickly assemble a PSUR from incomplete data or produce templated reports without examining the underlying evidence system, we're probably not the right fit.
Need a clearer view of what your post-market system requires?
We can review your current PMS, PMCF/PMPF, PSUR, SSCP, and evaluation update structure and identify where alignment, traceability, or maintenance risk may need attention.
Our clients care about documentation that holds up under Notified Body scrutiny, under competent authority review, and under the pressure of their own internal quality standards. That's the work we're built for.
Why SciMed for Post-Market Support?
A structured evidence lifecycle, not isolated documents
Many consultancies focus on individual deliverables. SciMed focuses on maintaining the underlying evidence system.
The distinction matters more than it might initially appear. When PMS data, PMCF findings, risk management updates, and PSUR outputs are treated as separate tasks — each completed in isolation, each handed off without a clear connection to the others — the documentation accumulates without cohering. Update cycles become increasingly difficult to manage. Reviewers spot the disconnects.
Our Approach
SciMed's approach is built around evidence continuity. We treat every post-market obligation as part of a single connected flow: The Evidence Thread
PMS Data
↓
PMCF / PMPF Findings
↓
Clinical / Performance Evaluation Updates
↓
Risk Management Review
↓
Risk Management Review
This traceable flow supports consistent benefit-risk conclusions, clear reviewer logic, and documentation that is defensible under audit because the underlying evidence system is genuinely aligned.
Maintaining that traceability is one of the factors regulators weigh most carefully during technical documentation review. It is also one of the hardest things to achieve without dedicated support.
Reducing Your Team’s Post-Market Burden
Many manufacturers manage post-market obligations with regulatory teams that were sized for a different era; before MDR and IVDR placed continuous evidence maintenance at the centre of the compliance framework.
The result is a pattern that we see frequently: spreadsheets holding the literature tracking together, PSUR updates triggered by deadlines rather than evidence cycles, documentation spread across teams who don't always have sight of what the others are doing.
None of this is careless. It is simply what happens when the volume of ongoing obligations exceeds the capacity of a team operating without dedicated post-market infrastructure.
SciMed functions as an extension of your regulatory evidence team. We handle the operational maintenance that keeps your documentation current; structured update cadences, monitoring support with human oversight, clear documentation governance; all so that your internal team can focus on the decisions that genuinely require their attention.
The outcome is a steadier regulatory environment: one where the next Notified Body review can be approached with greater control, visibility, and preparation.
The outcome is a steadier regulatory environment: one where the next Notified Body review can be approached with greater control, visibility, and preparation.
Proof: Post-Market Services Case Studies
See how SciMed has helped manufacturers bring structure to post-market evidence management, turning fragmented PMS, PMCF/PMPF, PSUR, and SSCP activities into traceable systems that support inspection readiness.
If your post-market documentation is becoming harder to maintain across update cycles, the same system-level approach can be applied to your evidence lifecycle.
Free Resources: See the Latest Post-Market Compliance Resources from SciMed’s MedTech Horizon
These resources address the operational challenges behind Literature Maintenance, PMS, PMCF, PMPF, PSUR, and SSCP requirements, written for regulatory teams who want to manage them more effectively, whether or not they work with us.
Build a Post-Market Evidence System That Stays Current, Traceable, and Review-Ready
SciMed helps manufacturers maintain post-market compliance through connected evidence systems, structured update cycles, and documentation that remains aligned year after year.
A compliant Post-Market Surveillance (PMS) system is not a reactive process. Under the EU Medical Device Regulation, it must proactively collect, analyse, and feed post-market data back into risk management, clinical evaluation, and corrective actions to demonstrate ongoing safety and performance throughout the device lifecycle.