Vaccines for Children

Vaccines for Children (VFC) & Vaccine Storage

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…

Friday Facts - Monitoring & Measurement of Processes

Monitoring & Measurement of Processes

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…

CVS site

Mesa Labs Compliance and Validation Services

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.

complaint box

Complaint Files

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…

Handling, Storage, Distribution

Handling, Storage and Distribution

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…

Device Packaging

Device Packaging

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…

Label Example

Device Labeling

Manufacturers 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…

Document Control

Document Control

Both 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…

Business talk

Personnel Requirements

The 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…