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Medical Device Security

Making a creative design into a trustworthy and marketable product requires undergoing Medical Devices

Overview : Medical Device Security Testing

Medical Device Penetration Testing identifies potential design weaknesses in the hardware, software, and communication techniques that could compromise the device's security. It aids businesses in comprehending the security implications of their devices and how to raise their level of security maturity. A component of the security testing procedure for medical equipment involves looking at every possible software flaw. Modern security testing methods make it possible to analyze the online safety of medical and healthcare items with accuracy.


Black Box testing is a type of software testing where no prior understanding of the underlying code structure, implementation details, or internal paths of an application is required. It is also sometimes referred to as behavioral testing or external testing. It concentrates on the input and output of the application and depends fully on the requirements and standards for the software.

Medical device testing


Why do organizations need Medical Device Cyber Security Testing?

cost efficient
enhancing security
cryptographic assaults
security features

Our Approach

The information gathering phase of the medical security testing approach is crucial. Document reviews and team talks will make up the preparation. The goal is for us to become familiar with the product and create a strategy in advance. This enables us to make the most of our time on location.

The following stage necessitates careful planning and research after information has been gathered through various informational technologies or by manual browsing. Defining the goals of penetration testing serves as the starting point for planning. Then, in order to ensure that everyone involved has the same knowledge of and goals, the tester and client collaboratively establish the goals.

The cybersecurity assessment and penetration test against your equipment will be carried out at the client’s premises. Our testing will involve locating all points of entry into the system, including Ethernet (LAN), Fiber, WiFi, USB, Serial Port, HDMI, and other points (we'll also look for others), as well as identifying the vulnerabilities related to each point of entry and carrying out initial and subsequent exploits of those vulnerabilities.

The goal of the reporting step is to present, rank, and prioritize findings as well as produce a concise, actionable report that includes all relevant supporting data for the project stakeholders. The most effective way to communicate results is through an in-person presentation of the findings. At Kratikal, we prioritize this stage and take great effort to ensure that we have effectively communicated the value of our service and findings. Upon completion,the report is delivered for evaluation via a web conference.

Our Clients

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What kind of certifications exist in medical security for cyber security?

    HCISPP (Healthcare Information Security and Privacy Practitioner), which is offered by the International Information System Security Certification Consortium (ISC)2, is the most well-known certification in medical cyber security. Other certifications include CHDA (Certified Health Data Analyst), CPHIMS (Certified Professional in Healthcare Information & Management Systems), and CAHIMS (Certified Associate in Healthcare Information and Management Systems).

  • Major cyber risks and threats in the healthcare and medical sector are -
  • a) Data breaches
  • b) Malware and Ransomware
  • c) DDoS (Distributed Denial of Service) attacks
  • d) Insider Threats
  • e) Phishing Attacks
  • f) Cloud Threats

    In the healthcare industry, medical device cyber security refers to safeguarding and securing medical equipment and systems that incorporate digital data or information. The protection of data and medical records at the hospital or any other medical facility is referred to as the assurance of security in the healthcare industry.

    The US FDA (United States Food and Drug Administration) is the widely respected standard that offers recommendations related to medical software and technology. The EU R (European Union Regulation) standard is also inferior to the US FDA. They offer rules that align security requirements with ISO norms.