Conducting a thorough hazard analysis is crucial for ensuring the safety and compliance of medical devices. Hazard analysis identifies potential risks and evaluates their impact on patient safety and device performance. At Periculo, we offer expert hazard analysis services to help you systematically identify, assess, and mitigate risks throughout the product lifecycle. Our approach includes detailed risk assessments, failure mode and effects analysis (FMEA), and the development of robust mitigation strategies. With Periculo’s support, you can ensure that your medical devices meet regulatory standards, enhance patient safety, and maintain high levels of performance and reliability.

Protect your software as a medical device from cyber threats with our specialised penetration testing services. We simulate real-world cyber-attacks to uncover vulnerabilities, providing you with detailed assessments and actionable insights. Strengthen your device security and safeguard patient data with our expert penetration testing.

Managing a Software Bill of Materials (SBOM) is critical for maintaining transparency and security in software development, especially in the healthcare sector. An SBOM provides a detailed inventory of all components within a software application, helping to identify vulnerabilities and ensure compliance with regulatory standards. At Periculo, we offer specialised SBOM management services, including creation, maintenance, and analysis of your SBOM. Our expertise helps you identify potential risks, ensure compliance with industry regulations, and enhance the overall security of your software products. With Periculo's support, you can achieve robust SBOM management, safeguarding your software from vulnerabilities and ensuring regulatory compliance.

Ensuring compliance with the FDA regulations is essential for any organisation producing or distributing medical devices in the United States. FDA compliance requires strict adherence to standards for safety, efficacy, and quality. At Periculo, we provide expert support to help you navigate these regulations effectively. Our services include comprehensive risk assessments, compliance audits, detailed documentation support, and advanced cybersecurity measures tailored to the healthcare industry. With Periculo, you can confidently meet FDA requirements, ensuring your medical devices are safe, reliable, and ready for the market.

To meet ISO 13485 compliance, a business must set up a strong quality management system (QMS) designed for the medical device industry. This means having clear and detailed procedures in place for every stage of the product’s lifecycle, such as design, production, and activities after the product is on the market. It also requires careful management of risks, close monitoring of suppliers, and keeping track of materials and processes. Regular checks, thorough staff training, and a focus on ongoing improvement are essential. The business must also ensure its practices follow ISO standards and meet the rules of the countries where its devices will be sold, ensuring products are safe and high-quality.

Having a Secure Development Lifecycle is a critical part of your Digital Health applications security. We work with our customers to advise them on how to implement secure best practices but also provide a managed service to add security into your development. We can do code scanning, bug identification and periodic penetration testing that scales as you grow. We can use your tools or our own.

Vulnerability scanning is crucial for ensuring the security of a system or network. By providing this service, we can help businesses and individuals identify weaknesses in their infrastructure, software, or configurations that could be exploited by malicious actors. This can ultimately help prevent data breaches, financial loss, and damage to reputation. We offer free vulnerability scanning to any of our customers.

RFPs - critical for your businesses growth but such a pain. Fortunately we love filling them out and have good processes in place for making the time spent more efficient over time. We start by building your own wiki from day one, which using our tools we can start to cut the amount of time that is needed. We work on both sides of RFPs so our consultants know how scoring processes work to help educate your teams on where is best to spend your time.

Ensuring compliance with the EU Medical Device Regulation (MDR) is crucial for any organisation dealing with medical devices in Europe. The EU MDR sets stringent standards for device safety, performance, and transparency. At Periculo, we offer expert guidance and comprehensive solutions to help you meet these requirements. Our services include risk assessments, compliance audits, documentation support, and cybersecurity measures tailored to the healthcare sector. With Periculo, you can navigate the complexities of EU MDR compliance smoothly, ensuring your medical devices are safe, effective, and market-ready.

To meet IEC 62304 compliance, organizations must follow clear steps to manage the lifecycle of medical device software. This includes creating and maintaining plans for developing, testing, and maintaining the software to ensure it works safely and effectively. The software must be classified based on the level of risk it could pose to users, with stricter rules for higher-risk software. Teams must also identify and reduce any risks or problems with the software as it is being developed and after it is in use. Regular checks, testing, and updates are essential, and all work must be carefully documented to show how the software meets safety and quality standards.

We specialise in helping healthcare providers and medical device manufacturers implement the NIST Cybersecurity Framework to safeguard against cyber threats. Our services include comprehensive risk assessments, vulnerability testing by CREST-certified penetration testers, and tailored framework alignment. We also provide compliance support, incident response planning, and continuous monitoring to ensure your medical devices remain secure and compliant with regulations like HIPAA and FDA guidelines.

Risk management is critical in SaMD development to identify, assess, and mitigate potential risks to patient safety and data security. This includes conducting thorough risk assessments and implementing appropriate controls throughout the software development lifecycle.

Regulatory requirements for SaMD vary by region but generally include standards set by organizations like the FDA in the US, the European Medicines Agency (EMA) in the EU, and other local regulatory bodies. Compliance typically involves demonstrating the software’s safety, efficacy, and performance through rigorous testing and documentation.

Common threats include malware, unauthorised access, data breaches, software vulnerabilities, and insider threats.

While these regulations have similar goals, they may have slightly different requirements and focus on different aspects of device security. For example, the EU MDR places a stronger emphasis on post-market surveillance, while the FDA's regulations focus more on pre-market clearance or approval.

To meet ISO 13485 compliance, a business must set up a strong quality management system (QMS) designed for the medical device industry. This means having clear and detailed procedures in place for every stage of the product’s lifecycle, such as design, production, and activities after the product is on the market. It also requires careful management of risks, close monitoring of suppliers, and keeping track of materials and processes. Regular checks, thorough staff training, and a focus on ongoing improvement are essential. The business must also ensure its practices follow ISO standards and meet the rules of the countries where its devices will be sold, ensuring products are safe and high-quality.