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Software as a Medical Device (SaMD) Security
End to end cyber security and compliance for medical devices. Simplified solutions to allow you to start, grow and scale. Let us remove the headache of security compliance.
Overview
We're here to support you with your journey through the complexities of compliance with standards like the EU MDR and FDA that are hurdles for medical device security.
An assigned expert will help you navigate and understand the EU MDR and FDA standards and regulations. They will work closely with you, ensuring you understand the processes and how cyber security is embedded within them.
Not only do we advise and support, we can manage the processes for you with our qualified team, saving you time and effort.
Our Medical device security experts have put together a series of guides and support documents to help with achieving EU MDR and FDA compliance - you can check out our blog posts for support.
Who is this for?
Medical device startups, scaleups and enterprises looking to enter the space
What does it cost?
Dependant on the level of support you need, we can tailor a service to you.
Services
We have a variety of services specific to ensuring the security of your medical device
Enhance patient safety and achieve regulatory compliance with our expert hazard analysis services. We meticulously identify and assess potential risks in your medical devices, ensuring you can mitigate hazards effectively. Optimise your device safety and meet industry standards with our comprehensive approach.
Protect your software as amedical 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.
Maintain precise control over your Software Bill of Materials (SBOM) with our professional SBOM management services. We offer tools and expertise to keep accurate records of software components, ensuring regulatory compliance and enhancing supply chain transparency. Streamline your SBOM management with our solutions.
Navigate FDA regulations effortlessly with our comprehensive FDA compliance services. We guide you through the complexities of regulatory requirements for software as a medical devices, ensuring a smooth approval process. Achieve and maintain high standards of safety and efficacy with our FDA compliance expertise.
Achieve ISO13485 certification seamlessly with our expert guidance. Our ISO13485 compliance services help you align your quality management system with international standards, ensuring consistent quality and regulatory compliance for your software as a medical device. Simplify your certification process with our support.
Secure your software as a medical device from the ground up with our Secure Development Lifecycle (SDL) services. We integrate robust security measures at every development phase, protecting your products from vulnerabilities and ensuring compliance with industry regulations. Build secure, reliable medical devices with our SDL expertise
Proactively protect your software as a medical device with our advanced vulnerability scanning services. We perform regular, automated scans to identify and prioritise security weaknesses, enabling prompt corrective actions. Ensure the safety and reliability of your devices with our expert vulnerability scanning.
Increase your contract success rate with our professional RFP support services. We assist in crafting compelling and compliant proposals that highlight your strengths and meet client requirements. Enhance your proposals and secure more contracts with our expert RFP support.
Ensure your medical devices comply with the European Union Medical Device Regulation (EUMDR) with our comprehensive services. We provide detailed guidance on meeting regulatory requirements, ensuring your products are safe, effective, and market-ready. Stay compliant and competitive with our EUMDR expertise.
Meet international standards for your software as a medical device with our IEC62304 compliance services. We assist you in implementing and maintaining a compliant software development lifecycle, enhancing the safety and reliability of your products. Ensure your software meets regulatory requirements with our IEC62304 expertise.
Still have questions?
Have a call with our founder or one of our experts to put together a free action plan.
How it works
Book a call
Everyone is different and medical devices are the same. It's important that we have some time to understand exactly what you need to be able to advise accordingly.
Select your services
We offer adhoc services for business that need a one off engagement, for example penetration testing. Or a managed service for any processes that you would like to have improved whilst saving you time to grow your business.
Grow your business
We have used security as a selling point for many medical device companies. Impress new customers when submitting RFPs, reduce your overheads and more forward with clarity.
Partnership
Our business model is to grow with our customers, this means we focus on building a partnership based on trust. It is in our best interest to provide you with the best possible service at the best level of quality.
FAQs
Find answers to commonly asked questions about software as a medicl device cyber security.
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.
Ensure the security of SaMD by implementing secure coding practices, conducting regular vulnerability assessments, using encryption for data storage and transmission, and following industry best practices for cybersecurity.
Common threats include malware, unauthorised access, data breaches, software vulnerabilities, and insider threats.
Periculo offers expert guidance and comprehensive services for SaMD development, including risk assessments, compliance audits, secure software development, and cybersecurity solutions. We help ensure your SaMD meets regulatory standards and is secure from potential threats.
Drop your email and we will organise a call
Free strategy session to help you improve your device and a free vulnerability scan to use when you like.
Sesilia Maidelin
Tech Associate, Doccla
Secure Your Software as a Medical Device (SaMD) Today
Contact Periculo for expert consultation on securing your medical devices and ensuring compliance.
