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Cybersecurity & Risk Management

MyVCM

MyVCM Information Security Framework

Ostendio’s proprietary framework, based on leading Industry Standards and Best Practices, is a 5 Stage Process, designed to guide organizations through developing and implementing a robust and comprehensive cybersecurity and risk management process. Clients completing the process have a comprehensive framework to manage their information security and risk and will be ready for a risk assessment or audit by a client or regulator. Ostendio Consultants can take you through the entire process or through individual stages.
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Risk Assessments

Conducting regular risk assessments is a critical part of an effective cyber security and risk management process. Identifying areas of vulnerability and implementing a plan to address those vulnerabilities will prevent an organization from being caught off guard. Ostendio offers Business Impact Assessments (BIA), Privacy Impact Assessments (PIA) and comprehensive Risk Assessments.
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Security Training

Strong security begins with people. Ensure key staff are trained on security policies and procedures. We provide Information Security Training as well as training on key Standards and Regulations.
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HITRUST Planning

Does your client require you to be HITRUST certified? Working with our Partners who are Certified HITRUST assessors, Ostendio will guide you on how to leverage the MyVCM platform in preparation for a HITRUST assessment, ensuring you have all the evidence and audit logs that HITRUST requires.

FDA Regulatory Compliance

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FDA Compliance

To support the development and operation of your FDA regulated solution, we offer a range of professional services for both the Quality and Regulatory aspects of FDA Compliance. This includes:

  • Quality Management Support & Representation
  • Regulatory Strategy and Submissions
  • Product Development Leadership & Support
  • Mechanical / Performance Testing
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Data Privacy and Cybersecurity

Medical Device companies must have a comprehensive cybersecurity and compliance program in place to protect sensitive data. Ostendio can offer you a range of cybersecurity and data privacy Professional Services solutions to help your organization develop a comprehensive risk and privacy program. This includes:

  • Cybersecurity and Risk Management program development and management
  • Privacy Standards and Regulation Compliance, for example HIPAA
  • Risk Assessments
  • Security Training
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Quality Management System Validation Documentation

FDA code 21 CFR 820.75 specifies that if the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated and documented with a high degree of assurance and approved according to established procedures. As a provider of systems that may perform one or many functions within the Quality Management System, Ostendio can manage control of records and change control processes. The Ostendio MyVCM platform validation documentation can be purchased per module, or for the entire platform. Customers may also subscribe to updates for every major release of the platform.

Affordable Care Act Section 1104

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CMS E2E

The Centers for Medicare & Medicaid Services (CMS) developed a new ‘enhanced’ direct enrollment (EDE) pathway for consumers to enroll in health insurance coverage through the Federally-facilitated Exchange. This new pathway allows CMS to partner with the private sector to provide a more user-friendly and seamless enrollment experience for consumers by allowing them to apply for and enroll in an Exchange plan directly through an approved issuer or web-broker without the need to be redirected to HealthCare.gov or contact the Exchange Call Center. Contact Ostendio Sales if you need support meeting CMS’ audit requirements.

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