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.