14+ Years of Expertise

Compliance and Validation Services Expert Spotlight

Mesa Labs’ Compliance and Validation Services expert Zach Sparks has more than 14 years’ experience in: IQ/OQ/PQ qualifications and temperature mapping of incubators, freezers, refrigerators, autoclaves, depyrogenation ovens, and lyophilizers. Cleanroom qualifications, including viable and non-viable particulate monitoring for routine monitoring and ability to determine the placement of the non-viable particulate measuring equipment to meet…

New Food Safety Regulations

FSMA: The Preventative Controls Rule

September 19, 2016 marked the day when larger businesses must comply with new standards set forth by the FDA’s Food Safety Modernization Act (FSMA). The first year of compliance will affect the larger businesses, generally those with 500 or more employees. Under FSMA, the FDA now can suspend facility registrations and has the authority to…

Flexibility = Cost Savings

Temperature Mapping; a Case Study

One of Mesa Labs’ clients has created an approach to harness the power of cells and optimize microbes for industrial fermentation. This customer needed to verify their autoclave cycle parameters and capabilities and also needed a system that could document temperature mapping. They preferred to rent equipment rather than sinking money into purchased items and…

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…

Is Risk Reduction Necessary?

Performing a Risk Evaluation

After completing your Risk Analysis, the next step is to perform a Risk Evaluation.  According to ISO 14971, “For each identified hazardous situation, the manufacturer shall decide, using the criteria defined in the risk management plan, if risk reduction is required…The results of this risk evaluation shall be recorded in the Risk Management File.” Risk…