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Our comprehensive service offers expert assessment to determine if a device qualifies as a medical device and identifies the regulatory requirements relevant to your target markets. Sii provides device classification, regulatory mapping, and customized guidance.
Our comprehensive service offers expert assessment to determine if a device qualifies as a...
Assessing the current state of your medical device, documentation, and development processes is essential for ensuring compliance with security regulations such as MDR 2017/745 or FDA (510(k)), and industry standards like ISO 13485, ISO 14971, and IEC 62304. Our comprehensive service provides a thorough evaluation to identify gaps and areas for improvement, helping you achieve regulatory compliance and quality assurance.
Assessing the current state of your medical device, documentation, and development processes is essential...
Establishing robust processes and documentation plays a pivotal role in upholding the standards of your medical devices. Our specialized service focuses on the meticulous implementation of key processes and documents, encompassing:
Establishing robust processes and documentation plays a pivotal role in upholding the standards of...
Maintenance is vital for sustaining the integrity and compliance of your medical device operations. Our tailored services encompass the management and upkeep of essential processes and documentation, ensuring ongoing regulatory compliance and operational efficiency.
Maintenance is vital for sustaining the integrity and compliance of your medical device operations....
Our comprehensive training program is designed to equip your entire project team with the expertise required to efficiently and effectively navigate every stage of your project.
Our comprehensive training program is designed to equip your entire project team with the...
Our service offers a systematic approach to identifying, assessing, and prioritizing security risks associated with medical device deployment. By thoroughly analyzing the ecosystem in which medical devices operate, we ensure the highest level of security for patients, healthcare providers, and stakeholders.
Our service offers a systematic approach to identifying, assessing, and prioritizing security risks associated...
We offer a comprehensive approach to designing robust security solutions that protect against evolving threats in healthcare environments, including countermeasures to effectively mitigate identified security threats.
We offer a comprehensive approach to designing robust security solutions that protect against evolving...
We ensure the integration of security countermeasures and best practices directly into the application code of medical devices. We adhere to industry standards and utilize cutting-edge techniques to fortify medical device software against potential vulnerabilities and threats.
We ensure the integration of security countermeasures and best practices directly into the application...
Through meticulous vulnerability assessments and penetration tests, we provide valuable insights into the security posture of medical devices, helping organizations identify and mitigate risks effectively.
Through meticulous vulnerability assessments and penetration tests, we provide valuable insights into the security...
Our proactive Monitoring services offer continuous oversight and vigilance to safeguard against potential threats and vulnerabilities. With a focus on introducing a robust Vulnerability Management process and implementing continuous monitoring against security incidents, we ensure the ongoing protection of medical devices in healthcare environments.
Our proactive Monitoring services offer continuous oversight and vigilance to safeguard against potential threats...
Our integrated safety and security controls for medical devices offer a holistic approach to ensuring both the safety and security of medical devices in healthcare environments. By addressing the intersection of security controls affecting safety and safety controls affecting security, we mitigate risks and enhance the overall resilience of medical device systems.
Our integrated safety and security controls for medical devices offer a holistic approach to...
MDR 2017/745: We comply with the Medical Device Regulation for the clinical investigation and sale of medical devices in the European Union.
FDA (510(k)): We adhere to the U.S. Food and Drug Administration’s requirements for premarket submission, clearance, and approval of medical devices.
ISO 13485 / 21 CFR Part 820: Our quality management systems align with international standards for quality management systems and the U.S. Quality System Regulation.
ISO 14971: We follow the risk management standards specific to medical devices to ensure the highest level of safety and effectiveness.
IEC 62304: Our processes for medical device software life cycle management adhere to internationally recognized standards.
IEC 82304: We ensure the quality and reliability of health software through compliance with this standard.
IEC 60601-1: We meet the standards for medical electrical equipment, ensuring safety and performance.
MDCG Recommendations: We follow the Medical Device Coordination Group's recommendations, such as the 2019-16 guidance on cybersecurity for medical devices and security risk management.
AAMI TIR57:2016: Our approach to cybersecurity in medical devices is guided by this technical information report.
AAMI TIR45:2023: We adopt agile practices in medical device development as recommended by this recent guidance.
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Natalia Competency Center Director
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