Quality Systems Compliance LLC
Steering the Path to Compliance

Quality Systems Compliance LLC is a highly successful medical device consulting company founded by Mark Durivage. Operating as a custom medical device consulting company out of Lambertville, MI, Quality Systems Compliance under the leadership of Durivage helps medical device manufacturing companies to achieve and maintain quality system compliance, meet deadlines, and curtail costs. Durivage is not your typical consultant with a degree in microbiology. Durivage began his career as a mold maker, a decision that bolstered his knowledge in various aspects of manufacturing, later earning a master’s degree in Quality Management. “Due to that early exposure, I understand the tooling, fixturing, and gaging aspects of manufacturing and the associated processing that goes into producing and assembling medical devices,” explains Durivage. “That’s rare in this industry.”

That practical functional knowledge of manufacturing and processing combined with his know-how of the inner workings of the FDA makes him a formidable ally to medical device

manufacturers. An avid follower of W. Edwards Deming’s theory of “Seven Deadly Diseases of Management,” Durivage reasons that Point No. 4—Mobility of Management—is one of the most significant issues plaguing medical device companies. Citing tribal knowledge and business continuity as key factors behind a sound quality management system, Durivage believes organizations can go from a state of compliance to non-compliant overnight. “By losing one key experienced person, the wheels can fall off the bus, and an organization can lose its ability to function in a compliant manner. Due to mobility of management, companies struggle to maintain a constant state of compliance. This is where I step in,” says Durivage, an author of several books that are dedicated to practical aspects of quality including process validation and process control.

When beginning a project, Durivage usually performs a gap analysis of the client’s systems and processes to assess their strengths, weaknesses, and identify compliance issues prior to designing and implementing a strategy that can aid them to achieve and maintain a state of compliance. As part of the strategy, Durivage focuses on patient safety and prioritizes the remedial actions accordingly. “Instead of trying to address all the issues simultaneously, I focus on the aspects that directly affect patient and user safety. In executing this proven strategy, I examine recent FDA Warning Letters and FDA Form 483 Observation and ensure that I’m focusing on the client issues relative to the current FDA requirements and expectations,” adds Durivage.

Readying Customers for Regulatory Challenges

As part of his remediation plan, Durivage provides training services. “I perform training as part of a value-add because by training the individuals and sharing the importance of regulations, standards, and guidance documents, I am preparing them to self-sufficient and ultimately successful down the road. Once the project is completed, the client should be able to maintain a state of compliance.”

In fact, Durivage realizes that clients who are not receptive to training and continual improvement are generally not successful in the long-term. “I am skeptical about projects where I feel the top management is not committed to training and improvement initiatives.”

During the path to compliance, Durivage reminds his customers (medical device manufacturers) that the ever-changing nature of the regulatory landscape requires constant vigilance.

I tell my clients, ‘what is acceptable today won’t meet tomorrow’s expectations.’ They need to commit to continual improvement, in order to remain compliant, and it is my obligation to make sure they do

“I tell my clients, ‘what is acceptable today won’t meet tomorrow’s expectations.’ They need to commit to continual improvement, in order to remain compliant, and it is my mission to make sure they do.”

Committed to ensuring his clients remain compliant, Quality Systems Compliance takes the onus of staying abreast with the latest FDA and industry related trends. Most recently, medical device companies have had to drastically alter their quality management systems and processes due to the release of ISO 13485:2016, the launch of the Medical Device Single Audit Program (MDSAP), and the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Durivage ensures his clients are kept informed about changes in regulations, standards, and guidances.

FDA Responses and Remediation

It is important to note that besides preparing medical device companies to tackle impending challenges of quality and regulatory compliance, Quality Systems Compliance is able to assist medical device manufacturers that have been issued FDA 483s or FDA Warning Letter. “When a client has received an FDA 483s or a FDA warning letter, I have to take a more calculated approach,” says Durivage.

To illustrate the impact of Quality Systems Compliance’s “remediation” services, Durivage narrates a customer success story.

The client had received several FDA Form 483 Observations and faced an uphill battle to keep the medical device on the market. Prior to contacting Durivage, the manufacturer sent an initial response to the FDA and received a notice from the FDA; the responses were unacceptable. When initially meeting with the site, Durivage discovered several issues in initial response that other compliance experts had failed to address. “I found things that they had admittedly ignored in the initial FDA response.” Durivage’s efforts included updating procedures, remediating CAPAs, NCRs, and complaints, and revalidating the equipment and manufacturing processes. The result was a successful subsequent FDA Re-Inspection with no findings.

Bringing a Diverse Skillset to Clients

Besides his proven manufacturing, processing, quality, and regulatory expertise, Durivage is also well-versed with supplier quality aspect of the medical devices manufacturing business. If a client is facing supplier quality issues, Durivage aids them with their supplier quality management system by implementing quality agreements and supplier process validations. “The supplier-customer relationship has changed—it’s more of a partnership today in which the customer and supplier must work together.

A lot of the small suppliers lack the technical expertise to perform process validations, and which places medical device manufacturers at risk. I help them bridge that gap, so the manufacturer doesn’t run into regulatory issues,” explains Durivage, noting that supplier issues are among the FDA’s primary concerns. “If your supply base is not sound, or robust, it can lead to significant regulatory and compliance issues. Investing time and money into your supply base is critical to avoiding regulatory exposure in the long run.”

Durivage serves a global clientele, having executed several projects in Europe and Asia. Durivage believes he can be an asset to foreign medical devices companies wishing to export products to the United States. “When foreign medical devices companies want to ship products to the US, they may be unaware of the nuances of FDA regulations and expectations. I have seen countless cases where foreign medical device companies misinterpret regulatory requirements and expectation and ultimately receive Warning Letters. Generally, these manufacturers do not have a consultant with the appropriate FDA experience advising them. I help guide and assist them successfully navigate through those regulatory and compliance challenges,” concludes Durivage.