Simplified medical device security
Overview
We're here to support you with your journey through the complexities of EU MDR and FDA compliance and medical device security.
Our Medical device security experts have put together a series of guides and support documents to help with achieving EU MDR and FDA compliance.
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.
How to tell if this is for you:
We'll provide advice, guidance and operational support for you to be compliant with various medical device security regulations such as;
EU MDR
FDA
CFR 21 part 11
ISO 13485
IEC 62304
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Advice, guidance and operational support for you to be compliant
We'll help you ensure that your medical devices are designed and manufactured with appropriate security measures to protect patient information and prevent unauthorised access to the device.
Supporting you to become compliant with these regulations can help ensure that your medical devices are reliable and perform as intended, which can improve patient outcomes.
Working with you to implement security measures to protect sensitive patient information, such as personal health information and personally identifiable information.
Helping you gain compliance with these regulations can help you avoid penalties and fines for non-compliance.
Gaining compliance with our support can make it easier for you to sell your products in different countries, as these regulations are recognised internationally.
With our support and advice understanding what it takes to gain compliance with these regulations can encourage you to invest in new technologies and security measures to improve the performance and security of your medical devices, which can ultimately lead to better patient outcomes and improved healthcare delivery.
Securing your medical devices and ensure compliance
You'll be designated an expert who can perform an assessment of your current systems and processes to determine your current level of compliance.
Based on the assessment, your expert can develop a plan to bring your systems and processes into compliance with the relevant regulations and standards.
Once the plan is in place, your expert can assist with the implementation of new technologies, procedures, and policies.
We won't disappear after the implementation, your expert can also review your systems and processes to ensure ongoing compliance and make any necessary adjustments in the future.
The purpose of medical device security regulations is to ensure that medical devices are designed, manufactured, and distributed with appropriate security measures to protect patient information and prevent unauthorised access to the device.
The main requirements of these regulations include implementing security controls to protect against unauthorised access, ensuring the confidentiality, integrity, and availability of patient data, and providing appropriate documentation and reporting to demonstrate compliance.
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.
Ensuring compliance with these regulations involves implementing security controls, performing risk assessments, and maintaining appropriate documentation. Working with a qualified consultant or compliance expert can also be helpful in understanding and complying with these regulations.
Consequences of non-compliance can include penalties, fines, and legal action. Additionally, non-compliance can damage a company's reputation and credibility and may lead to recalls or withdrawal of products from the market.
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