Medical Device Security and Compliance with MDR, IVDR regulations
Companies who chose us
MDR and IVDR regulations
for Medical Devices
It is a challenging task to secure devices against cyber threats while clients expect to preserve functionality without overcomplicated security measures.
The software usually connects to the internet or hospital networks, therefore data might be available through mobile phones or other connected devices.
We provide conformity assessments for numerous standards related to medical devices’ cybersecurity resilience.
Among many novelties linked to cybersecurity risks, two new regulations on medical devices have been adopted and entered into force on 25 May 2017.
These regulations introduce new essential cybersecurity requirements for all medical devices that incorporate electronic programmable systems and software that are medical devices in themselves within the EU.
This means that manufacturers have to develop and manufacture their products in accordance with the state of the art technologies and taking into account the principles of risk management.
The above affects information security, as well as requires to set out minimum requirements concerning IT security measures, including protection against unauthorized access to vulnerable personal data.
New Regulations on Medical Device Security
MDR
MDR Medical Devices
EU 2017/745
IVDR
IVDR In Vitro Diagnostic Medical
Devices Regulation; EU 2017/746
We offer instant advice and support to help you meet the Medical Device Security Standards
AAMI TIR57 - Principles for Medical Device Security - Risk Management
Creation and support of Risk Management files according to CyberSecurity
Provide expert opinion on the acceptability of all remaining risks for CyberSecurity
ISO/IEC 27001, ISO/IEC 27002 - Information Security Management and Security Techniques
Implementation of information security management systems and certification support
IEC/TR 60601-4-5 (IEC 62443-4-2)
Support of security level specification and determination of the safety aspects of medical devices
EN 62304 (IEC 62304) - Medical device software life cycle processes
Evaluation of medical device software requirements
safety assessment of software architecture
safety review of risk analysis
EN 60601-1 and EN 62304, IEC 82304-1 and EN 62304
Transformation or creation of design and development procedures for CyberSecurity
MDR / IVDR
User guide Support and review of CyberSecurity design
Assessment Services for Medical Device Security
ISO 81001-5-1 - Health software and health IT systems safety
Development environment security assessment
Gap analysis
Risk assessment for the development environment
Threat modeling
Our complex Medical Device Security solution includes the following services
Gap analysis
Risk assessment
Preparation for certification
Certification
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Testimonials
Kenneth Lasoski
Versa Networks
Evaluation team was extremely reasonable and flexible with resolution to findings and was helpful in finding agreeable solutions for CB comments. Consultation team was always responsive and helped shape the documentation for easier evaluation, and provided useful recommendations on satisfying SFR/SARs.
Thierry Bonda
Landis+Gyr
CCLab was well prepared, flexible during the whole evaluation process, and supported us with continuous communication and guidance. Many lessons were learnt during the project and CCLab has always been looking for solutions, supporting our developers the best way they could. The new Swiss evaluation methodology was a good and professional basis to work with, but both parties had to learn how to deal with it.
Jake Nelson
Corsec Security Inc.
The relationship between Corsec and CCLab has been instrumental in helping product vendors successfully complete the Common Criteria certification process. As a Common Criteria consultant to the product vendor, Corsec relies on CCLab’s responsiveness and expertise to quickly and thoroughly complete the testing component of the process. CCLab has been essential in managing multiple projects, their professionalism has helped ensure product vendor satisfaction and ultimate project success.
Alexander Testov
AO Kaspersky Lab.
"I would definitely recommend CCLab to anyone in need of Common Criteria certification. Our cooperation was comfortable, well organized and efficient. I am totally satisfied with the result."
Dayton Marcucci
HID Global
The CCLab team gave us full support to adapt to the changes during product development. Whatever the challenges faced they could keep the due dates and we were able to complete the process quickly and efficiently. The real agile lab helped our success. We are going to work with them again. I highly recommend them to anyone wanting to get its product certified.
Jaime Chica
NXP Semiconductors
It was a well-managed project which achieved success in an effortless manner.
Kalev Pihl
SK ID Solutions
We needed a lab that works quickly but with high work morale and quality of work. CCLab is exactly like that! It was good cooperation experience to work with them. The project was rather complex and our expectations maybe even too high, but the team was committed to the common goals and could keep the milestones; therefore we were able to deliver what was needed. I highly recommend CCLab team to anyone for their great team spirit, quality orientations, agility and reasonable pricing.
Israr Ahmed
Ascertia Ltd.
On behalf of Ascertia, accept my appreciation for the excellent job done by CCLab team over the past several months in achieving the Common Criteria Certificate for ADSS Server SAM solution. It was an enormous undertaking but went smoothly and efficiently! Thanks to your leadership and dedication combined with your staff's teamwork and energy, we achieved our target. You and your employees should take great pride in this accomplishment. We look forward to extend our work with you for our next certification milestone and hope will continue to get such excellent service.
Zsolt Rózsahegyi
I4P Informatics Ltd.
Thanks to the agile processes we've been able to add new features to the product during the evaluation that made it even more valuable to customers. CCLAB efficiently supported us throughout the whole change management process. The predictability, accurate scheduling, and supportive mindset helped us to finish the project in time.
FAQ
MDR Medical Devices Regulation
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )
IVR In Vitro Diagnostic Medical Devices Regulation
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. )
Why do medical devices need cybersecurity?
As medical devices get smarter features providing more efficient and easy-to-use solutions to patients the used technologies can introduce additional risks for patient health and their personal data. These smart features are usually implemented with software, internet connection and other IT technologies. These technologies introduce cybersecurity risks in the medical device and based on the device’s features, functionality and the data it handles it can become a target for cybercriminals. Health data is considered sensitive personal information therefore in case of a cyberattack where the attackers steal patient data or harm patient safety the manufacturer/developer of the device can face serious fines.
What are the current cybersecurity regulations on medical devices in the EU?
EU regulations on medical devices have been adopted and entered into force on 25 May 2017.
These are:
MDR 745/2017 - MDR Medical Devices Regulation; EU 2017/745
IVDR 746/2017 - IVDR In Vitro Diagnostic Medical Devices Regulation; EU 2017/746
How can manufacturers ensure medical device. security compliance?
Both regulations (MDR and IVDR) contain cybersecurity requirements. The goal of the policy makers was to create a regulation that ensures an industry standard security level without burdening market entities too much. The result is a risk-based approach where manufacturers/developers identify, analyze, and manage cybersecurity risks relevant to their product and create the necessary procedures and documentation to handle cybersecurity risks.
How can CCLab support medical device manufacturer companies in compliance to the latest regulations?
We offer “zero to hero” and integration services which help manufacturers/developers to achieve cybersecurity MDR compliance.
Our comprehensive services help from product design through development and MDR/IVDR certification. . They provide a clear path to compliance through methodology based on internationally recognized standards.
Integration services build on customers’ already implemented management systems that comply with relevant industry standards. Integration services help customers to utilize their already implemented processes instead of creating new ones.
What is the purpose of the usage of standards?
Compliance to internationally recognized standards eliminates quality discrepancies. A manufacturer/developer might think that a freshly designed and planned cybersecurity activity will be compliant to regulatory requirements but during the certification process the notified body might reject the evidence because of insufficient quality. Standards are created by a group of experts on the relevant field and contain every pertinent aspect of the topic. Compliance to internationally recognized standards ensures that designed and implemented security procedures are secure. It creates a common language between the manufacturer/developer and the notified body.
How long does a medical device evaluation period take?
As each project and product evaluation is different, there is no exact answer to this question. It depends on many factors such as product complexity and assurance claims. The certification time also depends on the selected certification body. Contact us @ info@cclab.com and we will help you put together a project plan and schedule.
How do i request a cybersecurity evaluation offer for my medical?
Please contact our sales team, and they will help you. You can reach us by email: info@cclab.com or mobile phone: +36 (20) 212 1664 .