About DQS
Design Quality Services (DQS) was established to support large and small innovators' product development endeavors, resolve quality system challenges, and provide technical training. The pathway to commercialization is complex, regulatory expectations can be ambiguous, and quality management systems (QMS) may become unstable. DQS brings a pragmatic approach to enable these pathways, fostering business growth and market success. DQS comprises a network of skilled professionals with experience resolving regulatory issues with global Notified Bodies and the US FDA. We are here to help you solve your toughest challenges.
Recent project successes:
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Rebuilt Design Control (DC), Risk Management (RM), and Post Market Surveillance (PMS) methods for a multi-site, global OB/GYN and IVF device manufacturer
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Transitioning DC methods from single-use mechanical only Ostomy devices to intelligent IoT/cybersecurity devices
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Created/implemented custom Process Validation (PV) and Test Method Validation (TMV) methods for an established spinal implant manufacturer
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Custom Design Verification sample size selection methods and tools for an innovative, complex medical device startup
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Upgraded d/p/uFMEA methods for a growing, ambitious medical device contract manufacturer to take on development projects
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Developed and implemented Usability Engineering methods for a multi-site, global, disposable device manufacturer in support of EU MDR
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Established new NC/CAPA processes and templates, along with PMS metrics, for a global, multi-site, IVD Reagents and Equipment manufacturer
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Independent technical/quality reviewer for start-up device companies to ensure robust development methods are in place
President DQS - John Salvato, PhD
John has an impressive 30-year career spanning quality assurance, manufacturing, and product development in the medical device and automotive industries. As the president of DQS, he brings exceptional engineering abilities and unparalleled global management experience. His leadership has led to successful development projects in various countries, including the US, Canada, Germany, France, the UK, Denmark, Japan, China, and Turkey.
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John has successfully merged many years of professional experience with his academic work. Check out his recent paper with Dr. Laplume:
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Agile Stage-Gate Management (ASGM) for physical products J. J. Salvato and A. O. Laplume (2020) R&D Management published by RADMA and John Wiley & Sons Ltd
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Certifications: FDA QSR, FDA Design Controls, ISO13485:2016 Lead Auditor, ISO14971:2019, IEC62304:2015, EU IVDR (2017/746)
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Experience: IEC62366, Process Validation, Supplier Audits, IEC60601, ISO10993, ISO15223, EU MDR, D/PFMEA, Design Thinking, Project Management, Design for Manufacturing, DVP&R, Post Market Surveillance (PMS), and others
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Contact
At DQS we mean what we say about supporting innovators. Let's talk about how we can help you unclog your technical and quality teams.
+1 269 720 7373