When determining how to best take care of and maintain your temperature monitoring system, it is important to consider the benefits of an annual service agreement. Technical Support While we do not anticipate issues with your system, we do want to have a plan in place if any were to arise. Our 24/7 technical support…
DetailsMesa Labs announces Compliance and Validation Services by launching a redesigned website to better highlight the areas where Mesa services can offer the most benefit. Having been a manufacturer of monitoring and validation equipment for decades, Mesa is uniquely suited to offer calibration and validation services as well as being ideally positioned to help its customers maintain compliance.
DetailsA requirement of ISO 9001, ISO 13485 and the FDA’s 21 CFR 820 is in regards to complaint files. According to 21 CFR 820, a complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is…
DetailsOnce product has been manufactured and packaged, there are requirements for how you handle, store and distribute the finished product. 21 CFR 820 breaks down the requirements for each of these processes. A manufacturing company should establish procedures that will deter mix-ups, damage, deterioration or contamination from happening during handling and storage of product. These…
DetailsUsually one of the last items you think of when designing a new product, the packaging actually provides a critical function. It is the barrier between the world and your medical device – meant to keep your product intact and functioning as designed. Medical device packaging must be tested for stability. This will provide assurance…
DetailsManufacturers are required to have labels for product and product labeling. According to the FDA in section 201, a label is a “display of written, printed, or graphic matter upon the immediate container of any article” whereas “labeling includes equipment labels, control labels, package labels, directions for use, maintenance manuals, etc.” 21 CFR 820 specifically…
DetailsBoth FDA’s 21 CFR 820 and ISO 9001 have requirements for document control. The goal with this section of the standards is to demonstrate that your quality system is compliant, that you design and manufacture products to meet design controls, and that your company is addressing risk management concerns. The FDA typically takes the approach…
DetailsThe FDA requires medical device manufacturers to have the appropriate personnel and training in place. According to 21 CFR 820, “each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.” Employees need to be trained so they can adequately…
DetailsAnother item that is required by both 21 CFR 820 and ISO 9001 is the Quality Policy. Though it is jointly written by management and quality experts, the process of writing a Quality Process is a beneficial exercise for management as it has them focus on systems and how the company operates. This document…
DetailsAs customers are the driving force behind any business, it makes sense to make sure they are taken care of. Does your company have processes and/or procedures in place to identify your customer’s requirements? For medical device companies, there are regulations in place from the FDA and ISO to make sure there are practices in…
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