Medical Device Cybersecurity Services

As a medical device company, you are expected to deliver innovative, lifechanging medical device(s) while ensuring compliance and achieving true quality. This task bears loads of responsibility - all which must be kept and documented within your quality management system.

America’s Security Corporation (ASC) will support your organization in adhering to security regulations and guidance, DHA Cybersecurity/Risk Management Framework (RMF) Requirements. ASC will help your organization achieve the initial Authority to Operate (ATO) and maintain an ATO during the medical device and equipment’s life cycle. ASC will facilitate the Reauthorization of your medical device and equipment in accordance with DoD RMF requirements: Per DoDI 8510.01 and in accordance with Appendix III of Office of Management and Budget (OMB) Circular A-130. ASC will perform an annual cybersecurity review or a negative change assessment to your system or environment at any time (i.e., a change increasing the residual risk). Negative change to your system or environment may result in a need for reauthorization prior to the regular three-year reauthorization.

ASC will support your organization with applying the RMF Steps and activities including Assessment and Authorization and Continuous Monitoring activities.