The Know-How to Know How

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Design, Process & Test Method Validation

Protocols & Procedures for Progress

Once your process is in place there is little room for error. However, with countless checkpoints and compliance regulations, it’s easy for things to fall through the cracks —especially when your staff or budget is stretched. Fortunately, many design, process and validation testing issues are avoidable. As medical device consultants, Medical Engineering Consultants can show you how to:

Define Your Testing Methods

Over-testing is a waste of time, money and manpower. MEC works with you to focus on a testing and sampling strategy that focuses on which parameters are mandatory to test and sample— and which aren’t — to meet all your criteria objectives. One thing we don’t test is your patience.

Avoid Costly Validation Failings

Do you need to validate all of your process parameters? What templates should you use? How do you organize and analyze all of your product code testing results? These questions should not be keeping you awake at night. The medical device consultants at MEC have been solving these concerns for more than a decade and they can solve them for any company.

Establish — and Follow — Protocol

Once your protocol is documented, procedures for follow-up need to be put in place. Getting everyone involved is critical, but your company’s real challenge is getting everyone to stay the course. When you don’t have time, or you’re short on support, the medical device consultants at Medical Engineering Consultants will work with you to find — and close — gaps, while keeping your people, procedures and protocols prioritized.

To strengthen your process, design or validation efforts, contact MEC.


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