ISO 13485 Medical Device Machining Services

Tanya DiSalvo leads Criterion Precision Machining as its third-generation owner, carrying forward a family legacy that began in 1953. Under her leadership, Criterion has become a nationally recognized woman-owned precision machining company certified to ISO 13485 and ISO 9001, and registered with the FDA and ITAR. Tanya has guided the company's strategic investment in advanced multi-axis machining technology, enterprise quality systems, and a culture of zero-defect manufacturing. Her commitment to the 'No Failure' philosophy has strengthened Criterion's position as a trusted partner to leading medical device, aerospace, defense, and photonics OEMs across the United States. Tanya's vision ensures that Criterion's 70-year heritage of precision continues to evolve to meet the demands of modern critical industries.

Mike Pinchot serves as Estimator and Project Manager at Criterion Precision Machining, acting as a critical bridge between customer requirements and the shop floor. With deep knowledge of precision machining processes—including Swiss turning, CNC turning, and 5-axis CNC milling—Mike ensures that every medical device project is accurately scoped, competitively quoted, and executed on schedule. He works closely with customers in the medical device, aerospace, and photonics sectors to translate complex engineering specifications into production-ready plans. Mike's project management discipline and estimating expertise are key to Criterion's ability to deliver mission-critical components with the reliability and documentation traceability that regulated industries demand.

David Glass serves as Chief Financial Officer at Criterion Precision Machining, providing the financial stewardship that supports the company's ongoing investment in advanced machining technology and quality infrastructure. His financial oversight ensures Criterion maintains the operational stability and capital discipline required to serve long-term OEM partners in regulated industries such as medical devices, aerospace, and defense. David plays a key role in sustaining Criterion's ability to invest in certifications, precision equipment, and the quality management systems that underpin its ISO 13485 and ISO 9001 compliance—ensuring the company is built for the long term and ready to scale with customer demands.

Kelly Marflak leads the Quality Management function at Criterion Precision Machining, overseeing the company's ISO 13485 and ISO 9001 certified quality systems. As Quality Manager, Kelly is responsible for maintaining the rigorous inspection protocols, documentation practices, and continuous improvement programs that define Criterion's zero-defect culture. She manages Criterion's advanced inspection laboratory—including the Global Advantage CMM, OASIS optical inspection system, and Keyence measuring tools—to ensure every medical device component shipped meets both customer specifications and regulatory requirements. Kelly's expertise in quality assurance is central to Criterion's ability to provide Certificates of Conformance, final inspection reports, and full traceability for every order.

Kellyanne Gottschalk manages Criterion's internal operational systems, including the company's ProShop ERP platform, which provides end-to-end visibility and control over every production order. Her role ensures that Criterion's workflows, documentation, and process controls are tightly integrated—supporting the traceability and compliance requirements of ISO 13485 certified medical device manufacturing. Kellyanne's systems expertise enables seamless coordination between estimating, production, quality, and customer service, ensuring that every medical device project progresses from order to delivery with accuracy, efficiency, and full audit-trail documentation critical to regulated industry standards.

Nilda Feliciano is the customer service representative at Criterion Precision Machining, serving as a primary point of contact for medical device OEMs, aerospace customers, and other partners across the United States. She ensures that customer inquiries, order updates, and project communications are handled with professionalism, accuracy, and the responsiveness that mission-critical manufacturing demands. Nilda's understanding of Criterion's capabilities—from Swiss turning to quality inspection—allows her to effectively support customers through every stage of the order lifecycle, from initial inquiry through final delivery, making her a valued link between Criterion's production team and its valued partners.

Bonnie Paletta serves as Office Administrator at Criterion Precision Machining, providing the organizational backbone that keeps day-to-day operations running smoothly. Her administrative expertise supports coordination across departments—from quality and production to customer service and finance—ensuring that the documentation, scheduling, and communications that underpin Criterion's ISO-certified quality management system are handled with care and precision. Bonnie's contributions help maintain the structured, compliant operational environment that medical device and other regulated industry customers rely on when partnering with Criterion for mission-critical precision machined components.