The Know-How to Know How
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Ironically, your success could very well be determined by detecting failure. The key, however, is to detect failure before it occurs. While no one plans to fail, the medical device consultants at Medical Engineering Consultants collaborate with you to minimize failure at every stage of your operation. Here’s how:
In the medical device and pharmaceutical industries, risk comes with the territory. Yet, companies that consistently come out on the winning side understand how to determine and manage risk. MEC designs customized Risk Management Systems that substantiate regulatory controls for both process and product. This leads to reduced patient risk, less money burned on validation costs and greater flexibility to find, fix and head-off problems that lead to failure.
If you don’t have the knowledge or personnel to focus on developing a complete and comprehensive Risk-Based Validation System, you’re taking the biggest risk of all. Medical Engineering Consultants has the know-how to protect both your company and your customers by failure-proofing every phase of your operation — from process planning and new equipment validation to initiating inspections for quality control and correctly responding to customer complaints.
The most effective way to control FMEA-associated risks is by designing top-down processes from a risk-based point of view. That can only be accomplished with a solid understanding related to the dynamics, diagnostics and documentation of FMEA sustainable solutions. To get FMEA knowledge ASAP, contact MEC.