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About DQS

Driven to Support Innovators

Design Quality Services (DQS) was established to support the product development endeavors of both large and small innovators, 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 leverages a network of skilled professionals with experience in resolving regulatory issues with global regulators.

We are here to help you solve your toughest challenges.

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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, Italy, Israel, Germany, France, the UK, Denmark, Japan, China, and Turkey.

John has successfully combined his extensive professional experience with his academic work.

Check out his recent paper with Dr. Laplume: 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

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  • ISO 13485:2016 Medical Device Quality Management System Lead Auditor
  • ISO 14971:2019 Risk Management
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  • ISO 13485 Medical Device Quality Management System Lead Auditor
  • Clinical Evaluation Report Training for EU MDR (2017/745) Compliance
  • Implementing the EU’s In Vitro Diagnostic Regulation (IVDR 2017/746)
  • Medical Device Cybersecurity Risk Management Training
  • Understand FDA’s Quality System Regulation (21 CFR 820)
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  • FDA Design Control (21 CFR 820.30)
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  • Introduction to Software for Medical Devices and IEC 62304:2015

Certifications

FDA QSR, FDA Design Controls, ISO13485:2016 Lead Auditor, ISO14971:2019, IEC62304:2015, EU IVDR (2017/746)

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

Ready to Equip Your Team With Proven Expertise?

Let’s get your medical device to market and your teams stronger.