Frequently Asked Questions

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We work exclusively with medical device organizations and manufacturers with established Quality Management Systems (QMS).  This includes medical device organizations manufacturing combination products.

We specialize in providing robust quality management system assessments and other support services for correcting or improving quality management system performance.  We work proactively to identify and correct quality issues before they occur or in preparation for upcoming audits.

We have experience assessing quality management systems against  global regulatory requirements and standards including: ISO 13485:2016, 21 CFR 820, EU MDR, ISO 14971, 21 CFR Part 4 and many more.

An independent, quality management system assessment stands in stark contrast to traditional internal or external audits, primarily due to its commitment to open communication. In this approach, the emphasis is placed on creating a collaborative environment where all stakeholders are encouraged to openly share their insights, concerns, and experiences. Unlike traditional audits, where information is sometimes hidden due to fear of repercussions or a lack of transparency, a collaborative assessment fosters a culture of trust and cooperation.

By promoting open communication, a VDC QMS Assessment ensures that no valuable detail is missed. This inclusivity allows for a comprehensive examination of your quality management system, uncovering both strengths and areas for improvement. 

The independent nature of a VDC QMS Assessment also provides you with an impartial perspective, free from internal biases. This objectivity can help identify and highlight issues that may have been previously overlooked or unaddressed in traditional audits. The result is a more holistic quality management system evaluation that identifies risks and opportunities for improvement more effectively, ultimately leading to a more robust quality system.

External audits, though valuable in their own right, do not always provide the most accurate measure of a quality system's overall health. This is primarily because external audits are conducted with specific external objectives in mind, are often based on a sampling approach, and are inherently targeted.

External audits are typically designed to serve a specific external purpose, such as regulatory compliance, contractual requirements, or risk assessment for a particular project. While these objectives are essential, they don't always encompass the comprehensive health and performance of the entire quality management system.

To truly assess the health of your QMS comprehensively, it's critical to take a holistic approach that considers not just compliance but also long-term quality excellence and continuous improvement. This type of insight allows organizations to gain a more well-rounded understanding of their quality management system's health and work towards lasting improvements.

Internal audits, while an essential part of a robust quality management system, do not always provide the most objective measure of performance. One significant limitation is that these audits are typically conducted by internal personnel who are already familiar with the organization's system and processes. This familiarity can lead to a lack of an independent point of view, potentially overlooking issues that an external perspective might uncover.

Another critical factor is that internal audits lack a collaborative nature that promotes open communication. Auditees are typically well-acquainted with the auditors and are frequently concerned about the consequences of exposing deficiencies. As a result, there can be a reluctance to share all relevant information openly, leading to a lack of transparency and a less complete understanding of important quality management system issues.

To address these limitations, an independent, comprehensive QMS assessment can be used to better identify deficiencies and areas for improvement.

Our consulting approach stands out as superior to others because we meticulously craft solutions that specifically address your most pressing needs. While other organizations and consultants offer a more generalized or less structured approach, our program is designed to be highly systematic and comprehensive with your end-goals in mind. Each step in our process is carefully planned and executed to ensure that no detail is overlooked, and all facets of your problems are addressed.

One of the key advantages of our program is its inherent adaptability.  It allows us to tailor our approach to the unique needs and challenges of your Quality Management System. This customized approach ensures, above all, that we deliver the results you require.

Moreover, our program emphasizes collaboration, transparency, and associate engagement. We work closely with you and your team at each step, maintaining open lines of communication and ensuring that you are actively involved in the decision-making process. This collaborative approach not only fosters a deeper understanding of your quality management system and requirements but also empowers you to take ownership of the solutions we co-create.

Our primary goal is to empower quality leaders by bolstering their ability to maintain high standards of quality, safety, and compliance within their organization. Simultaneously, we help drive substantial cost avoidance by reducing potential audit observations, recalls, and product complaints. 

When you partner with us, you can be confident we will identify opportunities to enhance the effectiveness of your quality management system, fortify your brand's reputation, and ultimately protect patient well-being, all while successfully mitigating the financial consequences linked to quality-related challenges.

A VDC QMS Assessment is recommended in various scenarios to ensure the effectiveness and compliance of your quality management system. 

Organizational Change: Whenever your organization undergoes significant changes, such as mergers, acquisitions, or high associate turnover, a VDC QMS Assessment is highly recommended. These transformative events can introduce new processes, cultures, and compliance requirements, potentially creating gaps in your existing QMS. By conducting an assessment during such periods, you ensure that your QMS aligns with the evolving needs and standards, providing a solid foundation for continued success.

Upcoming Audits: If you anticipate an audit on the horizon, preparing with a VDC QMS Assessment is a proactive move. Audits, whether internal or external, require meticulous compliance with regulations and standards. A VDC QMS Assessment will help you identify potential areas of non-compliance, giving you the opportunity to rectify issues before the audit, ensuring a smoother and more successful outcome.

Quality System Not Keeping Pace: When your organization is growing and evolving, your QMS must grow with it. If you find that your current QMS no longer aligns with your expanding operations, it's time to consider a VDC QMS Assessment. A QMS that doesn't scale with your company's growth can lead to inefficiencies, compliance risks, and a decrease in overall quality.  A VDC QMS Assessment will help you identify where improvements are needed to meet your new requirements effectively.

Recent Unassessed Changes: If your existing QMS has undergone numerous changes recently but hasn't been adequately assessed for their impact on QMS effectiveness, it's crucial to conduct a VDC QMS Assessment. These unassessed changes can introduce unforeseen risks and inefficiencies to your QMS and a VDC QMS Assessment will help ensure your QMS remains fully optimized and effective in its updated state.