Methods for Supplier Evaluation

There are a number of ways to conduct an evaluation of your suppliers.  To begin with, many organizations create a survey in which they outline various questions pertaining to quality systems.  Some companies consider ISO 9001 certification to be the best representation of control over production and quality, and therefore will evaluate the supplier based…

Quality Plan

In 21 CFR 820 Subpart B, the FDA states “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.  The manufacturer shall establish how the requirements for quality will be met.” A quality plan states the goals your company has to improve…

Device History Record

The FDA requires manufacturers to maintain Device History Records (DHR).  Within ISO 13485, there isn’t a specific requirement for a DHR, but it does require the manufacturer to create all of the individual records the FDA requires the DHR to contain.  The Device History Record is meant to be a collection of records containing all…

Mesa Labs Partners with Inteccon Inc.

Mesa Labs is pleased to announce our partnership with Inteccon Inc. (intecconinc.com) to become Mesa’s direct Master Distributor for Latin America and the Caribbean. Through the Master Distributor agreement, Inteccon will be representing the Mesa Labs DryCal Defender and Definer 220 gas flow calibrators as well as Mesa’s BGI lines of ambient air monitoring instruments.…