One of Mesa Labs’ clients, part of a large military installation, uses Mesa’s AmegaView wireless monitoring system to protect against product loss during power outages. AmegaView automatically calls when an asset goes into alarm, allowing our customer to react immediately. To read a more in-depth account of the clients’ needs and how Mesa experts were…
Mesa Labs is dedicated to helping our customers find the most appropriate solution to the challenges they face. One of our clients, Fort Meade Forensic Toxicology Drug Testing Laboratory, had difficulty regulating water flow and dealing with automatic system shutdowns, which caused a plethora of issues. By utilizing Mesa’s AmegaView software in conjunction with a…
Are you using digital data loggers? How about household refrigerator/freezers? How can you be confident that your vaccines haven’t been compromised? The Centers for Disease Control and Prevention (CDC) Vaccine Storage & Handling Toolkit aims to provide guidance on these and other questions. Published in 2014, the Toolkit discusses Vaccine Cold Chain, Transportation, Storage and Handling Plans,…
Are you using household refrigerator/freezers? How can you be confident that your vaccines haven’t been compromised? The Centers for Disease Control and Prevention (CDC) Vaccine Storage & Handling Toolkit aims to provide guidance on these and other questions. Published in 2014, the Toolkit discusses Vaccine Cold Chain, Transportation, Storage and Handling Plans, Temperature Monitoring Equipment, Best Practices…
A manufacturing company is required to have suitable methods in place for monitoring and measuring the processes involved in their quality management system. According to ISO 9001, “These methods shall demonstrate the ability of the processes to achieve planned results.” Essentially, what this requirement is asking you to do is to confirm that you’re having…
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…
Mesa 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.
A 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…
Once 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…
Usually 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…