What Experts See That Your Team Doesn't

One useful idea a month on device development, risk management, and quality systems. From someone who has spent thirty years finding out what actually went wrong.

Not regulatory summaries. Not news roundups. What actually shows up in FDA inspections and notified body audits, why it keeps showing up, and what well-functioning teams do differently.

Written for design, quality, and regulatory professionals who are adamant about career and organizational betterment offering ideas and tools you can use.

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John Salvato, Ph.D., is the founder of Design Quality Services. Thirty years in medical device and automotive quality assurance, product development, and manufacturing; certified ISO 13485 Lead Auditor, ISO 14971, FDA Design Controls, Cybersecurity Risk Management, and IEC 62304.

Kalamazoo, Michigan · designqualityservices.com