Survey: 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...
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 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 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 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 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 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 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 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 Article510(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 ArticleIndividualized Care, Big Data and Privacy
It seems with every key stroke, data is collected and stored by a third party. This huge amount of information may be a treasure trove for companies to learn more about the effectiveness of a treatment...
View ArticleWhen it Becomes Criminal
When the FDA warns of further enforcement, it is not just an attempt to intimidate. There are teeth behind this procedure and companies need to stand up and take notice. Ignoring or excessively...
View ArticleThe Road to Clearance - Avoiding Refusal
Continuing improvement of the 510(k) process took shape in late 2012. Medical device companies have been frustrated by the length of time it takes the FDA to review submissions. The agency believed...
View ArticleE-Health Services: The New Boon
E-Health services and wireless, wearable devices are spawning new products regularly. Last year monitoring devices grossed $2.9 million and is expected to grow to $17.1 million over the next five...
View ArticleRecalling the Difference
Last year the FDA issued a draft guidance to clarify the difference between a recall and a product enhancement. Only voluntary recalls are in scope and whether they are performed by the manufacturer or...
View ArticleChoosing a Contract Manufacturer- It's All in the Family
With increased scrutiny on the supply chain and rising complexities, finding a dependable manufacturing partner is critical. Outsourcing to a contract manufacturer may seem like an easy thing to do if...
View ArticleDevice Design Transfer - A Smooth Hand-off
Getting a new product into the customers hands as quickly as possible is critical to medical device manufacturers. Perhaps during the rush to hand off a product to the manufacturing floor, corners are...
View ArticleNot Obstructing the FDA - Be Reasonable
A little over a year ago, the FDA issued a draft guidance document (Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection) regarding the types of actions that would...
View ArticleMDR Perils –Avoiding Entanglement
The purpose of MDR reporting is to provide a means to collect data that may indicate the presence of a safety problem. MDR reporting can be confusing and it is certainly an area where mistakes are...
View ArticleBuilding a Culture of Quality- More Than Words Can Say
When questioned if their company has a focus on quality, most managers and employees will say yes. This might be because at a minimum, it is the right thing to say. They may also believe that since...
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