freyrsolutionsm

  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 ...

  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...

 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...

 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 ...

  Software as a Medical Device  (SaMD) refers to software intended to be used for medical purposes without being part of a physical medical device. It is designed to diagnose, prevent, monitor, treat, or manage medical conditions. SaMD plays a vital role in modern healthcare by enabling digital diagnosis, clinical decision support, and patient monitoring through computers, smartphones, and cloud-based as a Medical Device is defined as standalone software that performs medical functions on its own. Unlike traditional medical devices, SaMD does not require hardware components to operate. It runs on general-purpose platforms such as mobile phones, tablets, or computers and delivers healthcare-related outcomes.