BI Relocation

Mesa’s Biological Indicator (BI) Division is Relocating

Mesa announces that its individual manufacturing locations within the Biological Indicator Divisions of Mesa Labs (currently in Omaha, Nebraska, Traverse City, Michigan, and Bozeman, Montana) will be relocating into a new, state-of-the-art facility in Bozeman, Montana. Construction of the new facility is expected to be completed in January 2017.  The first site to be transitioned…

Reduce Potential Risks

Risk Controls

Based on the results of your Risk Evaluation, you will need to identify Risk Controls. Risk Controls are measures that you take with your medical device to reduce the identified potential risk(s) and/or their impact. ISO 14971 requires the manufacturer to “identify risk control measure(s) that are appropriate for reducing the risk(s) to an acceptable…

Risk Analysis

One part that contributes to the Risk Management Plan is the process of performing a Risk Analysis.  During this step, the goal is to define and analyze the dangers to individuals and/or businesses posed by potential adverse events.  In a broad definition, Risk Analysis can include risk assessment, risk communication, risk characterization, and any policies…

Catastrophe Prevention

Creating a Risk Management Plan

ISO 14971 breaks down all aspects of risk management.  One of the first steps to take in creating your risk management program is to create a Risk Management Plan.  For each medical device manufactured, “the manufacturer shall establish and document a risk management plan in accordance with the risk management process.” (ISO 14971:2007)  The Risk…

Focused on Design and Manufacturing

What is ISO 13485?

ISO 13485 is a stand-alone document that is similar in subject to ISO 9001, but with a direct focus regarding the manufacture and design of medical devices. There are a few key differences between the two standards, though. ISO 9001 has requirements for continual improvement of a company’s QMS while ISO 13485 just requires the…

Determine Needs and Opportunities

Continual Improvement

ISO 9001 has put an emphasis on the concept of continual improvement.  In the most recent version, Clause 10.3 states “The organization shall continually improve the suitability, adequacy, and effectiveness of the quality management system.”  The organization must consider the results of evaluations and the outputs from management review to determine if there are needs…

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…

Customer Satisfaction

ISO 9001 has identified the evaluation of customer satisfaction as one of the key measurements regarding the performance of a company’s quality management system.  There are many organizations that consider this a key indicator of corporate health. The goal of this requirement is to establish if the customer perceives that the company has met their…

Production & Service Control

ISO 9001 and ISO 13485 address the concept of Control of Production and Service.  In ISO 9001, it states “The organization shall plan and carry out production and service provision under controlled conditions.”  ISO 13485 expands on this by saying “The control must be performed and achieved according to the planning requirements specified…”.  Essentially, a…

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.