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ISO 13485 incorporation into US FDA

ISO 13485:2016 is a specialized QMS standard that ensures consistent regulatory compliance in the medical device industry. Its adoption into ISO 13485:2016 US regulations highlights a major regulatory evolution toward global best practices. Understanding ISO 13485:2016 The standard governs design, production, and post-market activities, emphasizing risk management and continuous improvement, ensuring effective ISO 13485 FDA compliance . Regulatory Integration The ISO 13485 incorporation into US FDA introduces the Quality Management System Regulation (QMSR), replacing traditional QSR and aligning with FDA QMSR ISO 13485 principles. Key Changes Enhanced documentation practices Lifecycle risk integration Stronger supplier management Benefits Improved safety and quality outcomes Simplified compliance across regions Greater global acceptance Operational efficiency Challenges Implementation requires cultural change, finan...
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SaMD global registration

  The convergence of healthcare and advanced technology has significantly reshaped how medical interventions are designed, delivered, and monitored. At the core of this evolution is Software as a Medical Device (SaMD) , which performs medical functions independently of any associated hardware device. Unlike traditional SaMD global registration , which is embedded within a physical product, SaMD functions autonomously across cloud environments, mobile platforms, and clinical decision-support systems. It enables diagnostic algorithms, remote monitoring, digital therapeutics, and AI-driven decision support, all powered by strong data pipelines and advanced analytics. As the ecosystem evolves, global authorities are accelerating efforts to define Software as a Medical Device regulation , harmonize expectations, and ensure patient safety, cybersecurity, data integrity, and performance. For manufacturers, navigating SaMD regulatory requirements while building scalable strategies for...
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How to Prepare Clinical Evaluation report CER under MDR

  The EU MDR has fundamentally changed MDR clinical evaluation by moving from a document-focused approach to a lifecycle-based, evidence-driven framework. Under the MDD, manufacturers often depended on static CERs, literature summaries, and equivalence claims without regular updates. Under MDR, clinical evaluation must be continuously planned, systematic, and transparent. It must confirm that a device’s safety and clinical performance remain acceptable when compared to the current state of the art, supported by solid clinical data. Understanding how to prepare clinical evaluation report CER under MDR is essential. EU MDR 2017/745 requires manufacturers to follow Articles 61 and Annex XIV, ensuring that clinical evaluation is ongoing and evidence-based. Manufacturers must demonstrate: Intended clinical performance achievement Data-supported clinical benefits Acceptable and minimized risks Continuous evidence validity A CER is no longer a stati...
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Corrective and Preventive Action (CAPA) Management Services

  We deliver end-to-end Corrective and Preventive Action (CAPA) management services customized for the medical device industry. Our solutions enable organizations to identify, investigate, and resolve quality issues while proactively preventing their recurrence. With strong expertise in Regulatory compliance and industry best practices, we assist your team with: Root cause analysis and risk assessment CAPA planning, implementation, and effectiveness verification Documentation aligned with FDA and ISO standards Integration with your QMS for streamlined quality oversight Our services support organizations in addressing quality concerns, preventing repeat issues, and maintaining compliance with global Regulatory standards such as FDA 21 CFR Part 820 and ISO 13485. What is CAPA? Corrective and Preventive Action (CAPA) is a systematic approach used to investigate and resolve quality issues while identifying their root causes. It was introduced in ...
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The FDA eSTAR Program

  The FDA eSTAR Program was developed to improve efficiency and consistency in preparing and reviewing 510(k), De Novo, and PMA submissions by the U.S. Food and Drug Administration. Building on the earlier eSubmitter approach for electronic medical device and IVD submissions, the eSTAR program reflects the FDA’s accumulated regulatory experience. It originated from the Electronic Submission Template and Resource (eSTAR) Pilot Program. Since October 1, 2023, 510(k) submissions require eSTAR, and De Novo submissions (unless exempt) will require eSTAR from October 1, 2025. Templates are available online and require FDA account credentials for submission. What is FDA eSTAR? eSTAR is an interactive PDF template designed to support the preparation of comprehensive medical device pre-market submissions. It also enables applicants to respond to FDA requests for additional information. The system enhances submission quality by ensuring the inclusion of complete and high-quality data for...
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Clinical Evaluation of Medical Devices

 Freyr serves as a reliable partner for the clinical evaluation of medical devices across all device classes. We develop comprehensive Clinical Evaluation Plans (CEP), perform reproducible Systematic Literature Reviews (SLR), and prepare Clinical Evaluation Reports (CER) that clearly demonstrate safety, performance, and EU MDR compliance — ready for Notified Body assessment. Clinical Evaluation of Medical Devices Overview Freyr delivers end-to-end Clinical Evaluation services supported by rigorous methodology, transparent State-Of-The-Art (SOTA) justification, and lifecycle maintenance. From CEP definition to CER authoring and PMCF integration, we align clinical evidence to General Safety and Performance Requirements (GSPRs) to support seamless EU MDR compliance and surveillance. Clinical Evaluation Plan (CEP) Freyr develops device-specific CEPs defining intended purpose, indications, claims, acceptance criteria, and equivalence strategy, supported by a reproducible SLR pr...
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Post-Market Surveillance for Medical Devices

 Post-Market Surveillance (PMS) of medical devices is a vital regulatory and quality function that ensures continued safety, performance, and real-world effectiveness after market entry. With evolving global regulations such as EU MDR and U.S. Food and Drug Administration post-market requirements, manufacturers must consistently monitor adverse events, analyze field data, and manage risks proactively. Freyr provides end-to-end post-market surveillance services, from complaint handling to PMSR/PSUR/PMCF reporting, helping organizations remain compliant, prevent recalls, and sustain market competitiveness. 1000+ PMS Reports, PMCF, SSCP 30+ Therapeutic Areas Supported 100+ PMS Reports, PMCF SSCP 99% On-Time Submission Speak to our Experts First Name* | Business Email* | Company | Message I have read the privacy policy Why Post-Market Surveillance Matters in the Medical Device Lifecycle Post-Market Surveillance (PMS) is a fundamental part of the medical device lifecycle, particularly ...
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