EU MDR Overview The European Union Medical Device Regulation governs the safety, quality, and performance standards for medical devices marketed...

Post-Market Compliance Strategy Expertise Once your medical device goes to market, it doesn’t mean you’re done with compliance. Medical device...

Quality Knowledge. Quality Systems. Quality Devices. Medical device quality system training is continuous and essential for getting on the fastest...

Team Member Spotlight: Kathy Johnson Broad Expertise. Collaborative Culture. Individual and Tailored Approach. At QA Consulting, we work as an...

Team Member Spotlight: Ella Wheeler Quality culture. Continuous improvement. Lean and Six Sigma. At QA Consulting, our team members strive...

Intro to MDSAP What is MDSAP? The Medical Device Single Audit Program (MDSAP) is a single regulatory audit of a...

FDA Inspection Observations (483s) — Current Trends and Preventing Escalation Ideally, you will have tactics and strategies in place to...

Your Device Made It To Market, Now What? Post-Market Surveillance How reliable is your device in the real world? Medical...

ISO 13485 Requirements and Audits: “What’s the Best Way of Doing This?” Align with the Latest Version of ISO 13485...