Medical Device Incident and Adverse Event Reporting Timelines in 6 Major Markets

It’s 3:00 p.m. on Friday and you’re ready for the weekend after a busy week. All of a sudden you are jolted back to reality by an email about a serious incident at a French hospital involving your company’s heart monitor. Details are sketchy and somewhat lost in translation. It’s now 9:00 p.m. at your office in Europe. They are closed for the weekend and you can’t get more details. Can it wait until Monday? If you’ve been in your […]

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6 Medical Device Compliance Issues That Will Demand More of Your Bandwidth in the Next 12 Months

The next 12 months are sure to be a wild ride for medical device RA/QA professionals. There’s a lot going on in the world of regulatory compliance and there is little doubt that your workload is about to increase – you may have seen it happening already. Here’s what we are hearing from our clients about issues they expect will consume more of their precious time this year. 1 – Internal audits and gap assessments The new European medical device […]

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Medical Device Postmarket Surveillance (PMS): Building a Process

This is the final article in a four-part series on Medical Device Complaint Handling. Download all four parts as a single PDF. Part 1: Medical Device Complaint Handling: Understanding the Basics  Part 2: Is That Medical Device Incident Reportable? Part 3: To What Extent Should You Investigate That Medical Device Complaint? Part 4: This post According FDA, postmarket surveillance is the process of “active, systematic, scientifically valid collection, analysis and interpretation of data and other information about a marketed device.” […]

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To What Extent Should You Investigate That Medical Device Complaint?

This is the third article in a four-part series on Medical Device Complaint Handling. Download all four parts as a single PDF. Part 1: Medical Device Complaint Handling: Understanding the Basics  Part 2: Is That Medical Device Incident Reportable? Part 3: This post Part 4: Medical Device Postmarket Surveillance (PMS): Building a Process LEVEL I: Conduct an initial investigation Confirm the complaint. Is the alleged deficiency actually a deficiency? Do you have enough information to investigate the complaint? Make earnest […]

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