Post-Market Support Services for Medical Devices
Our Post-Market Support Services ensure your medical device remains safe, compliant, and operational—combining PMS, PMCF, Regulatory Intelligence, Cybersecurity, and maintenance support across the EU, U.S., and other regulated markets.
Integrated Post-Market Services to Protect and Sustain Your Device
Our support services include Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), Regulatory Intelligence, Cybersecurity, and Maintenance & Field Support.
Post-Market Surveillance (PMS)
We provide ongoing monitoring of medical devices in line with MDR and FDA requirements, including real-time reporting, Periodic Safety Update Reports (PSURs), vigilance activities, and proactive feedback to your risk and quality systems, as well as compliance with other regulatory frameworks. PSURs are structured reports required by the EU MDR that collect and analyze post-market data to confirm the device’s continued safety and performance, and to update it’s benefit–risk profile based on real-world evidence.
Our vigilance and incident tracking system ensures rapid detection and assessment of adverse events, malfunctions, and complaints reported in the field. We provide structured workflows for triage, investigation, root cause analysis, and timely reporting to the appropriate regulatory authorities—helping you mitigate risks, maintain transparency, and meet mandatory vigilance requirements under EU MDR and FDA 21 CFR.
We support the development and maintenance of the SSCP, a mandatory document for Class III and implantable devices under EU MDR. This summary ensures that healthcare professionals and patients have clear, updated information about the device‘s safety and clinical performance. Our team ensures the SSCP reflects the latest data from PMS and PMCF, is appropriately written for its target audience, and remains compliant with MDCG 2019-9 guidance.
We analyze post-market data to identify statistically significant trends that may indicate emerging safety issues or product performance shifts. This includes evaluating complaint rates, device failures, and field service data to support timely integration into the Clinical Evaluation Report (CER) and used to inform risk updates and post-market strategies. Our reports allow you to refine benefit-risk conclusions, update mitigation measures, and remain audit-ready for Notified Bodies and competent authorities.
Post-Market Clinical Follow-Up (PMCF)
We design and execute PMCF strategies to continuously assess safety and performance, integrating findings with Clinical Evaluation Reports (CERs) and regulatory files. CERs are mandatory documents under EU MDR that summarize clinical evidence to demonstrate the ongoing conformity of a medical device with safety and performance requirements.
In the United States, while Clinical Evaluation Reports (CERs) are not required, the FDA mandates equivalent clinical justification through substantial equivalence rationale, clinical summaries, or post-approval study data, depending on the regulatory pathway. At D.med Technologies, we support the development and documentation of these FDA-aligned submissions to ensure our clients meet clinical evidence expectations across all global markets.
We develop PMCF plans in strict alignment with EU MDR Annex XIV Part B and applicable MDCG guidance. Each plan defines the specific methods and procedures to proactively collect clinical data on device safety and performance post-market. While PMCF is a formal requirement under MDR, our approach also addresses expectations from other regulatory frameworks, including FDA post-approval study models, ensuring alignment for global submissions.
We support the design and implementation of PMCF studies—whether through prospective. clinical registries, observational studies, or user experience surveys. Our team ensures scientific and regulatory robustness while minimizing operational burden. For devices marketed in the U.S., we also align registry designs with FDA 522 study guidance when applicable, offering a globally harmonized approach to post-market clinical evidence generation.
PMCF findings are systematically integrated into the Clinical Evaluation Report (CER), the Post-Market Surveillance Plan (PMSP), and other key regulatory documents to support decisions on risk updates and post-market strategies. This process includes re-evaluating the device’s benefit-risk profile, adjusting the frequency of PMS activities, and implementing changes to labeling, instructions for use, or control measures when necessary. In the U.S. context, we also incorporate FDA expectations for post-market surveillance reporting and risk mitigation documentation, ensuring full traceability and regulatory compliance across all relevant markets.
Regulatory Intelligence
Our team tracks global regulatory changes (MDR, FDA, ISO, LATAM, APAC) to provide early alerts, analysis, impact assessments, and to take any required corrective or strategic actions.
We help you track and manage your medical device registrations and regulatory updates with automated, risk-based systems prioritizing changes according to device class, geographic market, and lifecycle impact. This ensures critical updates are addressed first, improving compliance efficiency and audit readiness.
Our regulatory intelligence workflow delivers timely alerts on new or revised regulations, guidance documents, and standards across major regions including EU, U.S, LATAM, and Asia-Pacific. Each alert is contextualized to your product portfolio and regulatory obligations, with expert commentary when implications are unclear. This enables your team to act proactively and avoid compliance gaps due to missed or delayed interpretation of changes.
We support strategic planning that integrates regulatory updates into product lifecycle management, including changes to labeling, CERs, technical documentation, and market access strategy. Our documentation support extends across the EU (MDR Annex II & III), FDA submissions (510(k), PMA), and other regional dossiers, ensuring traceability and justification for every regulatory-driven change. This safeguards your product’s continuity and reinforces your regulatory positioning in global markets.
Cybersecurity Post-Market
We offer vulnerability monitoring, FDA-aligned patch management, and MDR cybersecurity compliance for connected medical devices. This not only reduces patient risk but also protects the company from regulatory penalties and product recalls.
Post-Market Vulnerability Scanning
Our vulnerability scanning services continuously monitor deployed medical devices to detect potential security flaws that may arise from new software releases, third-party integrations, or evolving threat landscapes. We use automated and manual tools to assess device integrity across hospital networks, home-use environments, and cloud platforms. This enables early remediation and reduces exposure to both patient harm and regulatory action, in line with MDR Annex I (17.2) and FDA premarket/postmarket cybersecurity expectations.
FDA-Aligned Security Patch Management
We provide structured patch management protocols aligned with FDA post-market guidance and ISO/IEC 29147 for coordinated vulnerability disclosure. Our process includes vulnerability verification, risk assessment, patch development, validation, and controlled deployment. These protocols are documented within your quality management system (QMS) and can be integrated with your PMS and CAPA systems to ensure traceability, compliance, and rapid threat response.
Cyber Threat Documentation & Risk Re-evaluation
We document cybersecurity incidents and vulnerability events in compliance with both MDR and FDA cybersecurity expectations, ensuring that all findings are analyzed and reflected in your risk management file and design history file (DHF). Each threat triggers a structured risk re-evaluation process, enabling updates to risk control measures, labeling, IFU (instructions for use), and software architecture where needed. This continuous loop supports both clinical safety and market access durability.
With the increasing connectivity of medical devices, cybersecurity has become a critical component of post-market risk management. Our cybersecurity services include real-time vulnerability scanning and full compliance with FDA 21 CFR guidance.
Why Choose D.med for Post-Market Support?
With a consolidated international track record, D.med delivers post-market solutions precisely tailored to each client’s challenges and objectives. Drawing on extensive experience in regulated environments, D.med has developed a proven methodology that blends practical innovation, regulatory excellence, and measurable outcomes—ensuring every solution is both compliant and market-ready.
Commitment to quality: We are certified under ISO 13485, ensuring that every stage of our process adheres to the highest international standards for medical device quality and documentation.
Speed with precision: Our optimized workflows accelerate compliance and field readiness without compromising quality—helping you gain a competitive edge in the evolving medtech landscape.
True adaptability: We tailor our medical device design services to the specific needs of your project, taking into account its technical complexity, regulatory maturity, and position in the development lifecycle.
Our complementary services enhance post-market compliance and operational efficiency.
Contact our experts today to tailor a post-market support plan for your device.
Frequently Asked Questions
What is the difference between PMS and PMCF?
What is the difference between PMS and PMCF?
Post-Market Surveillance (PMS) involves the ongoing monitoring of a device’s safety and performance after it’s on the market. Post-Market Clinical Follow-up (PMCF), in contrast, is the specific collection of clinical data required under the Medical Device Regulation (MDR) for continued clinical assessment.
Post-Market Surveillance (PMS) involves the ongoing monitoring of a device’s safety and performance after it has been placed on the market.
Post-Market Clinical Follow-up (PMCF), in contrast, refers to the specific collection of clinical data required under the Medical Device Regulation (MDR) to support the continued clinical evaluation of the device.
Why is regulatory intelligence important post-launch?
Why is regulatory intelligence important post-launch?
Regulatory intelligence helps identify changes in relevant laws and guidelines that affect compliance. This enables proactive adaptation and ensures market access.
How does cybersecurity fit into post-market Surveillance strategy?
How does cybersecurity fit into post-market Surveillance strategy?
Cybersecurity minimizes patient and data risks throughout the product lifecycle. We ensure safe connected operation with up-to date protections.