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Validation Consulting

Unlock the Value of Validating Processes, Equipment, Software and Strategy

At some point, many medical device and pharmaceutical companies find themselves either short on staff or short on expertise. This is when key benchmarks get missed and important details start disappearing in the cracks. The next thing you know, your company is non-compliant and playing catch-up. Medical Engineering Consultants helps companies through these tough times by providing the expertise, knowledge and competence required to validate potentially hundreds of checkpoints for each individual process.

Validation Needs to Be Built into Your Execution

Even when your company’s processes and full quality systems are in place, your company still needs qualified personnel to validate your strategy. MEC Validation Consulting services bridge your personnel and expertise gaps while closing the holes that are — or have the potential to become — a burden on your business. Here is how MEC can guide you towards FDA approval:

  • Create a Comprehensive Master Validation Plan: Put a full plan in place that defines exactly what must be validated for every given process ... and how deep you need to go.

  • Develop, Execute and Design Validation Protocols: Install operational process and product protocols at different levels that reduce costs via first-time pass validations.

  • Maximize Efficiency through Validation-Powered Execution: Save time and money by learning from design, process, software and equipment validation testing, statistical analysis and reports.

  • Push Productivity via Proper Process Protocols: Put Operational Qualification and Product Qualification protocols in place to get the most from your process and people.

  • Connect Your Process to Your Design: Simplify the complicated relationship between Process FMEA (PFMEA) and Design FMEA (DFMEA).

When your company is looking for validation, secure it with Medical Engineering Consultants.

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