510(k) Clearance Without the Snags
In the US, there are two regulatory processes used to obtain marketing clearance for a device. 510(k) is a type of premarket submission where there is a substantially equivalent predicate device....
View ArticleWhat Keeps You Up at Night? 2014 in Review for Medical Device Companies
Quality compliance is never a static concern. With changes in programs and new guidance documents it may feel like trying to hit a moving target. During online discussions, many device manufacturers...
View ArticleMDSAP: Another Attempt at a One Size Fits All Audit
There are significant challenges to meet the regulatory requirements to sell products globally. It is necessary to be audited by regulators from these countries or by an accredited independent group....
View ArticleLife Sciences Executive Webinar Series - "Mastering Compliance and Innovation"
Merit Solutions and OnShore Technology Group are excited to launch a new monthly Life Sciences Executive Webinar Series titled "Mastering Compliance and Innovation”. This series will identify ways Life...
View ArticleGreen Validation Webinar: Automating the Validation Process
Managing validation document lifecycles and deliverables can be error-prone and time-consuming. Which leads to the question: "Can paperless validation be a reality?"Join us for our Green Validation...
View ArticleMedical Device Security-Beyond a Data Breach
In today’s technology obsessed world, even the delivery of healthcare is dependent on software driven devices. Some are standalone, others are networked together. With the ever growing web of...
View ArticleDevice Add-Ons- Separate but not Equal- Maybe.
The FDA has recently issued guidance regarding the risk of device accessories. They will no longer be considered as part of one big happy family included in the risk of the parent device. This new...
View ArticleThe New Inspectorate
It has been a little over a year since the FDA issued a memo outlining the reorganization they would undertake to change inspection activities. This plan is expected to better align resources in order...
View ArticleCompliance: Robust Reporting is Key
Government regulations are becoming more prevalent and we can only expect this trend to continue. Just because they don’t touch your business today doesn’t mean they won’t in the near future....
View ArticleSurvey: Life Sciences Industry Mobile Adoption
Merit Solutions is interested in feedback on the prevalence of mobile software solutions within the Life Sciences Industry. We would like to better understand the views of executives in the Life...
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