.svg)
Pharma Companion Apps 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.
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.
Services
We have a variety of services specific to ensuring the security of your app
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 app from cyber threats with our CREST penetration testing services. We simulate real-world cyber-attacks to uncover vulnerabilities, providing comprehensive assessments and actionable insights. Enhance your device security and safeguard patient data with our expert penetration testing solutions.
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.
ISO13485 compliance is essential for medical device manufacturers to demonstrate their ability to provide medical devices and related services that consistently meet customer and regulatory requirements. It is a globally recognised quality management standard specifically for the medical device industry, addressing areas such as risk management, regulatory compliance, and traceability. Achieving ISO13485 certification can enhance market access and credibility for manufacturers, ensuring the safety and effectiveness of their products.
Implementing a secure development lifecycle (SDL) for Pharma Companion Apps is essential to ensure its safety, efficacy, and regulatory compliance. The SDL integrates security at every stage of development, from initial design to deployment and maintenance. At Periculo, we specialise in guiding you through a comprehensive SDL process. Our services include threat modelling, secure coding practices, rigorous testing for vulnerabilities, and ongoing security assessments. By partnering with Periculo, you can ensure that security is embedded in every phase of development, resulting in safer, more reliable products that meet stringent regulatory requirements.
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 comprehensive support for RFP (Request for Proposal) processes, ensuring that your business can submit high-quality and competitive proposals.
In order to comply with IEC62304, software must follow a risk-based approach throughout the software development life cycle. This standard outlines processes and activities that need to be undertaken to ensure the safety and effectiveness of medical device software.
Still have questions?
Have a call with our founder or one of our experts to put together a free action plan.
FAQs
Find answers to commonly asked questions about Pharma Companion Apps Security.
Security is crucial for pharma companion apps because they handle sensitive patient data, including personal health information (PHI). Ensuring security protects patient privacy, complies with regulatory requirements, and maintains user trust.
Ensure security by implementing strong encryption for data storage and transmission, using secure coding practices, regularly updating the app, and conducting thorough security audits and vulnerability assessments.
Data privacy regulations like HIPAA, GDPR, and other regional laws set strict requirements for handling PHI. Compliance involves ensuring data is securely stored, processed, and shared only with authorized parties.
Ensure compliance by implementing robust security measures, conducting regular audits, staying updated with regulatory changes, and seeking expert guidance from cybersecurity professionals like Periculo.
Best practices include adopting a secure software development lifecycle (SDL), conducting regular security testing, ensuring data encryption, complying with regulatory standards, and providing user education on security practices.
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.
Patrick Connor
CEO, Joy
