Elevate Solutions Group Shares Leadership Discussions Regarding its Medical Device Injection Molding Initiatives
A Three-Part Series: Part One: Manufacturing
Part Two: Tooling
Part Three: Quality and Compliance
In this segment: How ISO 13485, validation, and documentation impact supplier selection
Austell, GA | April 2026
Interviewer: Chris Gardner, VP of Sales & Marketing
Interviewee: David Mathenge, Quality Director
In this third installment of our leadership Q&A series, we spoke with David Mathenge, Quality Director at Elevate Solutions Group, about regulatory expectations, validation discipline, and what medical device OEMs should look for in a manufacturing partner.
Gardner: You’ve spent much of your career in medical manufacturing environments. What distinguishes a medical-device quality system from those used in general manufacturing?
Mathenge: The biggest difference is the level of structure, documentation, and risk management required. In medical device manufacturing, every process must be designed with patient safety and regulatory compliance in mind. That means documented procedures, validated processes, traceability, and clear evidence that we consistently produce conforming product. It’s not enough to have a good process—you must be able to demonstrate control, repeatability, and continuous monitoring.
Gardner: As you prepare to take Elevate Solutions through ISO 13485 certification, what should this look like from a customer’s perspective?
Mathenge: When we chose to pursue medical device OEMs, we completed an ISO 13485 gap analysis. We were already ISO 9001-certified, and our QMS was structured to follow the ISO 13485 medical device standard many years ago. As a result, our QMS was already well positioned for this progression. For customers, it means they can expect disciplined change control, validated processes, risk-based thinking, and strong documentation practices. It also means the organization is structured to support regulatory compliance throughout the product lifecycle—from early manufacturing through full-scale production.
Gardner: Medical OEMs operate under strict regulatory oversight. How are you positioning your team to ensure manufacturing processes align with those expectations?
Mathenge: Our approach is to mirror the expectations of the regulatory environment our customers operate in. Strong document control, formalized risk management practices, process validation, and robust corrective and preventive action systems are critical. These systems create a manufacturing environment that supports both regulatory compliance and consistent product quality.
Gardner: Risk management is a central concept in medical manufacturing. How does your team approach risk when launching new molded components?
Mathenge: Risk management starts early in the product lifecycle. We work closely with engineering and manufacturing to identify potential risks related to tooling design, molding parameters, materials, and downstream processes. Using structured risk assessment tools allows us to identify potential failure modes early and implement controls before production begins. We want to design QUALITY into the process.
Gardner: Validation is critical for many medical programs. How does your team approach process validation for injection molding?
Mathenge: Process validation in injection molding ensures that a manufacturing process consistently produces product that meets defined specifications. This typically involves structured IQ, OQ, and PQ activities. We evaluate equipment capability, establish operating windows, and confirm the process produces stable, repeatable results under normal production conditions. The documentation generated during validation becomes part of the permanent quality record for the product.
Gardner: Documentation and traceability are often major concerns for medical device customers/OEMs. What systems are most important to maintain that level of control?
Mathenge: Traceability and documentation are foundational in regulated manufacturing. Material traceability, lot tracking, and comprehensive production records ensure that every product can be traced back through the manufacturing process. Strong document control systems also ensure that procedures, specifications, and quality records are maintained in a controlled and auditable manner.
Gardner: Supplier quality is another critical area for medical device programs. How does the quality team manage suppliers and incoming materials?
Mathenge: We evaluate suppliers based on capabilities, certifications, and ability to meet quality and regulatory expectations. Once approved, we maintain controls around incoming materials, documentation, and change notifications. This ensures that materials entering our facilities consistently meet the standards required for medical applications.
Gardner: You manage a lot of customer and regulatory audits. When we say we are “audit ready,” – what does that look?
Mathenge: It comes down to consistency. When quality systems are implemented correctly and followed every day, audits become much less disruptive. Documentation is current, processes are controlled, and employees understand their roles in maintaining compliance. It becomes part of the culture rather than something you prepare for only when an audit is scheduled.
Gardner: Quality cannot operate in a silo. How do you collaborate with manufacturing and tooling teams to ensure robust processes?
Mathenge: Fortunately for us, our manufacturing and tooling leadership each have decades of experience with medical device manufacturing. They understand quality and validation requirements, and our teams meet regularly to establish program needs. This team approach leads to more stable processes, fewer surprises during validation, and better long-term production performance.
Gardner: What quality indicators should medical device OEMs look for when evaluating a contract manufacturer?
Mathenge: My advice is to look beyond certifications and evaluate HOW quality systems are implemented. Things like process validation discipline, documentation practices, risk management, and audit readiness all provide insight into how a manufacturer operates. Ultimately, our customer’s goal is to partner with a supplier that treats quality as a core part of its culture – as we do.
In Closing
“Medical device manufacturing demands discipline, consistency, and trust. Those principles guide how we build processes, lead teams, and support our customers every day. Elevate Solutions Group has made strategic hires like David to bring deep industry experience to the table. This series is designed to share insights from some of those key individuals.”
Chris Gardner, VP of Sales & Marketing
About Elevate Solutions Group
Elevate Solutions Group is a rapidly growing, vertically integrated contract manufacturer serving medical, telecommunications, consumer, and industrial markets from its modern campus just outside Atlanta in Austell, Georgia. With more than 30 injection molding presses ranging from 80–950 tons and 240,000+ square feet of ISO 9001-certified, FDA-registered operations, ESG delivers customer-centric focus in precision molding, packaging & assembly, kitting, warehousing, and full 3PL services. Elevate’s capabilities include designing, engineering, producing, and assembling complex products as well as holding stock and shipping globally through a data-driven distribution center. https://esgworks.com/