Our Managing Director is a thought leader in Healthcare Cybersecurity Industry, with over two decades of experience working in cybersecurity and technology. In addition to developing and leading a Product Security program at one of the largest healthcare companies in the world, Colin has supported numerous organizations building medical technology with their cybersecurity needs.
Product Security Engineering Support
Provide ongoing product security & engineering support, including design discussions and reviews, analysis of security testing results, answering questions from regulatory agencies, completing questionnaires from healthcare delivery organizations and more.Learn More
Regulatory Submission & Go to Market Support
Lead and perform key cybersecurity activities, including architecture/data flow diagram development, threat modeling, requirements documentation, support with security testing support with V&V testing, labeling (IFU, MDS2 development) and submission guidance.Learn More
Cybersecurity & Quality Management System Integration
Develop processes, work instructions and templates for product security and fully integrate with a quality management system, including the updating of existing procedures (e.g. design control, design & development, risk management, complaint handling, etc).Learn More
Questions and Answers
Frequently Asked Questions
Read about some of the issues and challenges that others have faced while navigating the complex world of device cybersecurity
Digesting the plethora of cybersecurity requirements and industry standards to understand what they need to build in their product. Ask us. WE KNOW.
We have extensive experience partnering and collaborating with the FDA on industry initiatives and guidance documents. Through these efforts, we are in constant communication with key members of their cybersecurity team.
It’s Our Approach – we become partners with our clients, helping to support and guide them every step of the way. As we perform and deliver our work, we take the time to educate, provide guidance and train key stakeholders. Our goal is to help the organization better understand the medical device cybersecurity universe, so it is not so daunting and scary.
UNDERSTANDING THE INDUSTRY
The Medical Device Cybersecurity Industry is Growing. We Know, We’ve Been There Since the Beginning.
Limited Human Capital
This is a rapidly expanding space and there is a significant shortage in cybersecurity professionals, let alone ones that have experience in healthcare. Organizations are taking months to find a candidate to hire and then 12-18 months to properly train them. So, you’re looking at investing >2 years in a person before they are in a position to positively impact the organization.
Regulatory agencies and customers are enhancing and expanding their requirements of device manufacturers. This combined with the ever-growing list of industry standards is making it a challenge with medical device manufacturers to keep up and ensure they are managing cybersecurity properly.
Technology is growing at a rapid pace in healthcare, but the ability to secure it is struggling to keep up. Healthcare continues to be one of the biggest targets of cyber attacks and enhancing technology increases risk. The difference with healthcare is the impact is human life. It literally can be a matter of life and death.
APRACITI was started to help medical technology companies that do not have the cybersecurity knowledge or expertise required. We do not want cybersecurity to be a roadblock in getting a new lifesaving technology to market, rather our goal is to support these organizations so they can bring safe, secure, trustworthy devices of the highest quality to market.
Cybersecurity Support For Organizations Developing Medical Devices or Healthcare Technology.
Expert & Professional
Proven industry thought leaders
We are available round the clock
Clients can rely on us