Software as a Medical Device Security & Compliance

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.