QA/RA Consulting, Auditing & Training
QMSR Is Taking the Spotlight, But MDSAP Still Deserves Attention Why does MDSAP still deserve attention? Because “we’ve aligned to QMSR” and “we’re ready for MDSAP” are not the same thing. At some point in a lot of QMSR transition efforts, things start to feel pretty good. Processes have been updated. Risk-based thinking is getting […]
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The Medical Device Single Audit Program: How to Prepare for (and Maintain) MDSAP Certification The Medical Device Single Audit Program (MDSAP) is a cooperative effort between the medical device regulators in the US, Canada, Japan, Australia and Brazil. Argentina, South Korea, and Singapore participate as affiliate members. The challenges of preparing for your first MDSAP […]
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MDSAP Mock Audits – Getting QA and RA on the Same Page As companies grow larger, they often split the responsibilities of QMS management and regulatory compliance. Typically, QA will handle ISO 13485, FDA QSR, product quality, CAPA compliance, and so on. Regulatory tends to manage product registrations, clinical evaluation reports, risk management, and the […]
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FDA 510(k) Safety and Performance-Based Pathway Simplifies the Clearance Process for Well-Known Devices. Here’s How It Works. Each year, FDA clears thousands of medical devices via the 510(k) process. An overwhelming majority of those devices (80%+) go through the Traditional 510(k) process. Less than 2% go through the alluring Abbreviated 510(k) process. Why? Well, frankly […]
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MDSAP Mock Audits ├óΓé¼ΓÇ£ Getting QA and RA on the Same Page As companies grow larger, they often split the responsibilities of QMS management and regulatory compliance. Typically, QA will handle ISO 13485, FDA QSR, product quality, CAPA compliance, and so on. Regulatory tends to manage product registrations, clinical evaluation reports, risk management, and the […]
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On October 31, 2017, Health Canada announced new guidelines intended to reduce some of the burden that the new MDSAP rules placed on smaller medical device companies. At that time, they promised a 10-20% reduction in audit times for companies with fewer than 45 employees. However, it seems industry was unimpressed with those efforts, because […]
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