Software as a Medical Device (SaMD) refers to software intended to be used for one or more medical purposes without being part of a physical medical device. With the rapid growth of digital health solutions, AI-driven diagnostics, and mobile health applications, ensuring SaMD regulatory compliance has become essential for market approval, patient safety, and global commercialization.
Document Management is the process of capturing, storing, organizing, securing, and retrieving documents in a structured and efficient way. It helps organizations manage both digital and physical documents throughout their lifecycle, ensuring easy access, compliance, and data security.Document Management is a foundational component of efficient business operations and regulatory compliance. By adopting a robust document management system, organizations can improve control, enhance collaboration, reduce risks, and ensure that critical information is always accurate, secure, and accessible.
ISO 14971 Risk Management Consulting helps medical device manufacturers establish, implement, and maintain an effective risk management process throughout the entire product lifecycle. ISO 14971 is the international standard that defines how to identify hazards, estimate and evaluate risks, control those risks, and monitor the effectiveness of controls to ensure patient safety and regulatory compliance.Our ISO 14971 consulting services support organizations in building a structured, compliant risk management framework that aligns with global regulatory requirements, including FDA, EU MDR, and
Quality Management System (QMS) Services for Medical Devices are essential for ensuring that medical device manufacturers consistently meet regulatory requirements, maintain product safety, and deliver high-quality products to the market. A well-implemented QMS helps organizations comply with international standards such as ISO 13485, FDA 21 CFR Part 820, and EU MDR, while improving internal processes and reducing compliance risks.QMS services involve the design, implementation, maintenance, and continuous improvement of a structured quality management framework specifically tailored for the m
Software as a Medical Device (SaMD) refers to software that is intended to be used for one or more medical purposes and performs these purposes without being part of a physical medical device. Unlike traditional embedded software, SaMD runs on general-purpose platforms such as computers, tablets, or smartphones and plays a direct role in diagnosis, monitoring, prevention, or treatment of diseases.SaMD is widely used in modern healthcare for clinical decision support, diagnostic imaging analysis, patient monitoring, and digital therapeutics, making it a critical component of digital health ecos
IEC 62304 Compliance refers to adherence to the international standard that defines the software life cycle processes for medical device software. This standard is essential for manufacturers developing Software as a Medical Device (SaMD) or software embedded in medical devices, ensuring safety, quality, and regulatory acceptance across global markets.IEC 62304 provides a structured framework for planning, developing, testing, maintaining, and retiring medical device software in a controlled and traceable manner.
In the highly regulated and complex field of neurology, achieving timely global regulatory compliance and successful market entry requires deep expertise, precise strategy, and strong execution. Freyr played a pivotal role in enabling a neurology-focused organization to navigate diverse regulatory landscapes, streamline approvals, and accelerate product commercialization across key global markets.
Global market expansion for Software as a Medical Device (SaMD) focuses on bringing digital health solutions to patients and healthcare providers across multiple countries while meeting regional regulatory, clinical, and commercial requirements. As healthcare systems increasingly adopt digital technologies, SaMD companies must strategically plan entry into key markets such as the US, EU, UK, India, and APAC regions.