Assessments/Auditors

If you are looking to obtain an independent assessment of a supplier or your system, processes, and procedures, then let us come in and provide you with an unbiased view. Assessments of either IEC 62304 or IEC 82304 systems (SiMD, SaMD, and HealthIT) are things we perform on a daily basis.

In the end, you shall receive recommendations appropriate for your organization’s size, and maturity; this will enable you to develop your software environment into a world-class system.

Cybersecurity

Your company’s reputation could be put at high risk in this age of constant cyber-attacks on our infrastructure, hospital facilities/structures, and product data. The harm or potential harm one must survive from a security breach incident is a threat to any business, government, or person. And Patient data is sacrosanct, where besides the loss of confidentiality, one is subject to fines as high as $25,000 per record leaked. Our methods are to build the proper process, procedural, cyber threat assessment, and record examination to create a robust barrier against Cyber risks.

Design Control

We have successfully released scores of products from Class I – III under varying strategies in order to leverage organizational sources and provide the best speed to market result. Whether it is through the release by contract manufacturers, private label, or keeping core development in-house, we could help you commercialize a product that is on time, within cost, and meeting quality/reliability requirements.

Design Verification and Validation

Need assistance in developing a master validation plan or to review and hardened your approach test strategy, let us offer you our guidance. By providing you with a template for success, you’ll obtain a robust test strategy that provides appropriate risk management and appropriate rationale for sample size, reliability, and confidence. Thus ensuring your device’s successful proof of safety, efficacy, and essential performance.

Independent Reviewers

We are able to come in and perform the code-level reviews, test strategies, and challenge design deliverables. Or maybe one truly needs an unbiased expert assessment of software development deliverables throughout the phases, then let us come in and diplomatically provide you with this service.

Remediation

We have led DHF remediations large and small. By performing a thorough needs assessment and analysis, we could save you literally thousands of man-hours and provide a meaningful resolution for your remediation efforts. This shall enable you to successfully navigate through any ensuing audits and meet the regulatory and/or quality requirement.

Risk Management

Practical, realistic, and full-proof risk analysis requires real-world experiences. Too often, software risk management is performed without a true direction or guidance and provides nonsensical results. Variations and what-if scenarios rule the thought process and instead of getting a solid risk management plan in place, one obtains an indiscriminate plan which is not realistic. We have utilized Failure Tree Analysis (FTA), Failure Modes and Effects Analysis (FMEA), Software Risk Analysis, and other tools for differing software classes and provide a realistic outcome that could be used to further cement your ongoing, clinical, complaints, and internal failure analysis and risk assessment.

Unit Acceptance Testing and Human Factors

Providing users with a positive experience is the goal of user acceptance testing and the Human Factors experience. But ultimately, one wants to deliver the right product for the marketplace which enhances a patient’s quality of life. At the same time, one cannot deliver a product that a physician/staff finds burdensome to use, is too time-consuming, and has a high cost to purchase/maintain. With our approach, you should get to the resolution required to offer the best product.

Software Tool Validation

Create the right solution. Most organizations either perform overkill or nothing, let us offer you a realistic approach that is manageable on a long-term basis.

Submission Support

Assist in preparing the software documents for 510(k), PMA, and IDE Submissions including; Procedures, Plans, User Needs, Requirements, Specifications, Hazard/Risk Analysis, Test Plans, Test Cases, Test Summaries, and Trace matrices. We also provide support for the entire submission since the software works hand in hand with the product.

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We started our careers in the industry when both the FDA and Europe started taking a harder look at Design and Development. We offer practical service solutions to your development and remediation efforts.