The Know-How to Know How
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When your company is unable to control your systems, your systems will control your company. The most effective way for medical device companies and manufacturers to stay in control is by expert implementation of — and adherence to — current Good Manufacturing Practices (cGMP).
However, implementation is only half the battle. Enforcing a system you can’t adhere to will only make resources harder to manage, blow up budgets and cause your staff to feel trapped. As cGMP regulatory approval and compliance experts with operational backgrounds, Medical Engineering Consultants can advise you on how to protect your process, products, pipeline and profitability.
The worst time to uncover quality concerns is during rework, recalls and responsive field actions. Those are the most significant factors that affect your total cost of quality. Putting cGMP Quality System Regulations in place from the start is the smart way to implement problem prevention and early detection safeguards. Without them, it won’t matter how far you have progressed because it’s going to result in considerable regrouping, rechecking and redoing. MEC understands cGMP and can help you establish the guidelines you need for product quality impact during every phase of production.
There are many unknowns in medical device production. Product quality impact and manufacturing production should not be two of them. The cGMP Quality System Regulations consultants at MEC can help you:
Ready to talk cGMP? Talk to MEC.