Streamline Your Healthcare Compliance with Our Compliance Assessment Software

Experience seamless and efficient medical device compliance with RiskWatch’s Compliance Assessment Software. Our platform offers comprehensive tools for risk assessment, ensuring your healthcare organization meets all regulatory standards. Simplify your compliance journey with RiskWatch

Riskwatch dashboard

Everything you need to achieve and maintain Medical Devices Compliance

Streamlined HIPAA compliance management using our risk assessment tools, automated workflows, centralized registers, and risk monitoring.

Utilize pre-built HIPAA Compliance framework, risk assessment, access control, policy, and audit for safeguarding sensitive data.


Ease to use software to effectively complete your HIPAA Security Risk Assessments in a timely and painless manner.

RiskWatch offers intuitive dashboards showcasing real-time HIPAA metrics on controls and risks, enhancing decision-making.

The Challenges

Compliance Officers in medical device companies face a multitude of challenges, including difficulty in understanding complex regulatory requirements, implementing necessary controls, and maintaining compliance over time.

Performing effective audits requires quality frameworks to ensure that the company’s practices are meeting industry standards and comply with applicable regulations such as FDA regulations and ISO 13485. Audits are time-consuming and professionals need more time to analyze progress on mitigation and spend less time collecting and analyzing data.

Teams need assistance developing a road map for evaluating risks, identifying opportunities, and making informed decisions on how to mitigate risk. Protecting your products, preventing costly penalties, and maintaining your reputation are major challenges for all involved.

The Impact

Our customers have reported a previous inability to fully manage their compliance due to an unorganized risk management process that relied on unreliable manual processes, ultimately leaving them exposed and vulnerable.

Without a reliable platform to streamline audits and automate key functions such as report writing and data analysis, these customers were struggling to complete their required audits. This left numerous gaps over extended periods of time while teams prioritized the wrong projects in an effort to feel productive while data was still being collected and scored.

Achieve your Medical Device Compliance Goals with RiskWatch

Automated Medical Device Compliance Management

RiskWatch software streamlines the medical device compliance assessment process, using our intelligent analysis methodology to collect all relevant security data and highlighting any security gaps. Our automated MDR compliance management aims to improve security positioning without the need to manually compare site data and risk scoring prioritizes projects, allowing you to manage medical device company security without getting stuck in the weeds.

Automated Compliance Management
Streamlined Security Risk Assessments

Streamlined Medical Device Security Risk Assessments

RiskWatch enables customers to streamline Medical deice industry Security Risk Assessments, completing necessary tasks with ever-increasing efficiency. Our medical device company Compliance Solution automates functions such as communicating with designated staff members, analyzing data, providing recommended remediation, and writing custom reports.

Pre-built Content Libraries for
Compliance Automation

RiskWatch offers over 50 prebuilt content libraries that are ready for use in our platform. These libraries contain industry standards and regulations, including Medical device regulatory compliance, lending subject matter expertise and guidance for organizations. Compliance with these libraries ensures risk is minimized, aiding in effective healthcare compliance automation.

Pre-built Content Libraries for Compliance Automation

Can You Afford Medical Device Regulatory Non-compliance?

In 2017, St. Jude Medical was fined $12 million by the FDA for failing to properly investigate problems with the batteries in its implantable defibrillators, leading to two deaths. The company had received reports of rapid battery depletion in some of its devices but failed to adequately address the issue. 

Gaps in compliance leave your organization vulnerable to attacks and penalties, ultimately limiting growth, damaging reputation, and declining morale.

Ready to get started and automate your compliance process?

RiskWatch platform is easy to use, free to try, and can be customized to fit your business needs.


Get answers to some of the most frequently asked questions on our HIPAA Compliance Risk Assessment Platform.
Or head over to the Contact Us page to have a compliance expert reach out to you.

HIPAA Compliance refers to the adherence to the regulations set forth by the Health Insurance Portability and Accountability Act (HIPAA). This act sets the standard for protecting sensitive patient data. Any organization dealing with protected health information must ensure that all the required physical, network, and process security measures are in place and followed

HIPAA compliance is important because it ensures healthcare providers, health plans, healthcare clearinghouses, and business associates of HIPAA-covered entities must implement multiple safeguards to protect sensitive personal and health information. It helps maintain trust, mitigate legal and financial risks, promote efficient operations, prevent data breaches, and enhance reputation.

Enhanced Security: HIPAA Compliance ensures the protection of sensitive patient data, thereby enhancing the overall security of healthcare organizations.

Regulatory Adherence: Compliance with HIPAA helps healthcare organizations adhere to state and federal laws, as well as industry standards.

Risk Management: By adhering to HIPAA regulations, healthcare organizations can effectively manage and mitigate risks associated with the handling of sensitive patient data.

Efficiency: RiskWatch’s platform streamlines the process of achieving HIPAA compliance, thereby increasing efficiency.

Automated Processes: The built-in automation capabilities of RiskWatch’s platform remind users of assessments and assigned tasks to be completed, thereby ensuring continuous compliance.

Real-Time Risk Profiles: RiskWatch’s platform provides real-time risk profiles and scores that update as changes occur, helping organizations stay on top of their compliance status.

Cost Savings: By streamlining the compliance process and reducing the risk of non-compliance penalties, RiskWatch’s platform can help healthcare organizations save unnecessary costs.

Reputation Management: Compliance with HIPAA can enhance a healthcare organization’s reputation by demonstrating its commitment to protecting sensitive patient data.


By providing a HIPAA Compliance Assessment platform to manage and meet multiple regulatory compliance audits and requirements. It includes the entire HIPAA standard.

The role of automated analysis in HIPAA Compliance is to streamline the process of collecting information and producing quantifiable reports1. It minimizes human errors and handles large volumes of data3.

RiskWatch prioritizes HIPAA risk management by providing a centralized platform that simplifies compliance tracking, reduces risk, and ensures your organization is always audit-ready.

By providing real-time risk profiles and scores that update as changes occur.

RiskWatch can help in reducing unnecessary costs by streamlining the compliance process, reducing the time spent on assessments, and minimizing the risk of non-compliance penalties.

The main features of the RiskWatch platform for HIPAA Compliance include Compliance automation,
Pre-built content libraries,
Document storage,
Accuracy and scalability, Collaboration,
Report generation

RiskWatch streamlines HIPAA Compliance assessments by automating workflows, streamlining compliance tasks, and assigning and tracking tasks.

Pre-built content libraries in RiskWatch are libraries that contain industry standards and regulations, lending subject matter expertise and guidance for organizations.

Additional content libraries can be added in RiskWatch by choosing from custom criteria using our Bulk upload option to perform custom assessments. 

To generate detailed and customized reports, providing a comprehensive view of your risk profile and compliance status.

RiskWatch compares to manual processes by offering a more efficient and accurate way to manage risk and compliance. It reduces the time spent on assessments and minimizes human errors.