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How to avoid a medtech document scavenger hunt
Take a few moments to consider the importance of the documentation of your medical device company.
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Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
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Devices & Diagnostics, MedCity Influencers
5 predictions for the medical device industry in 2018 (and how you can prepare)
From the EU MDR/IVDR being revised to the MDSAP program going live, regulatory changes have been rampant and significant for medical device professionals.
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Debunking 8 commonly held CAPA myths
Here’s a compilation of myths and realities about Corrective Action and Preventive Action (CAPA), the system for addressing systemic quality issues for medical device companies.
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Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
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What should trigger a CAPA in medical device manufacturing?
Corrective Action and Preventive Action (CAPA), a system for addressing systemic quality issues for medical device companies, is frequently overused, which can overburden businesses with unnecessary work, or when underutilized, trigger FDA warning letters.
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Devices & Diagnostics, MedCity Influencers
5 predictions for the medical device industry
From a new FDA commissioner to 510(k) review times, here’s what to expect in the way of medical device industry changes this year.
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3 tips for managing your medical device design history file
The medical device Design History File is the proof companies will need to give the FDA that all of the design control regulations were assiduously followed.
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Devices & Diagnostics, MedCity Influencers
6 tips to reduce likelihood of a rejection for an FDA 510(k) submission
Nearly 70 percent of 510(k) submissions were rejected the first time round between January and June of 2015. Here’s what you can do to reduce the likelihood of that happening to your company.