Capability Studies

Medical device manufacturing demands absolute precision and repeatability. At MedFab Precision Solutions, we employ intensive capability studies to verify that our machining processes can consistently produce parts within the tight tolerances demanded by our customers and the patients they serve.

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MedFab: Your Rapid Prototyping Powerhouse

At MedFab, we know that prototyping is essential in bringing your concept into reality. From preliminary conceptual and visualization prototypes to functional alpha and beta versions, to the final pilot prototypes, our rapid prototyping services have helped our customers prove concepts, secure funding, optimize viability, and identify and address manufacturing issues, avoiding costly mistakes and saving valuable time once production begins.

Capability Studies in Medical Manufacturing

Medical devices require extreme accuracy, often down to microns, to ensure proper function and biocompatibility. Using statistical analyses of process capability index (Cp) and process capability ratio (Cpk), MedFab can assess the performance of its manufacturing processes at any time, determining the stability, repeatability, and capability of that process for producing parts that meet the customer’s specifications.

Conducting capability studies benefits both MedFab and our customers in multiple ways, including:

Ensuring consistent adherence to customer specifications
Reducing process variability and the risk of defects
Improving efficiency while maintaining the highest quality standards
Affirming compliance with ISO 13485:2016 and FDA regulations

Integrated Quality Assurance

Capability studies are a core part of our comprehensive quality control system, which also includes:

First Article Inspection (FAI) – Verification of part dimensions before full production
Production Part Approval Process (PPAP) – Ensuring compliance with customer and regulatory standards
Gage R&R Studies – Confirming measurement system reliability
Failure Modes and Effects Analysis (FMEA) – Identifying and mitigating potential process failures
Statistical Process Control (SPC) – Continuously monitoring and optimizing production

Unsurpassed Precision

MedFab is committed to delivering high-quality, high-precision machining solutions with unfailing consistency. By investing in statistical process control, capability studies, and other intensive quality assurance measures, we guarantee the ongoing ability to meet and exceed the expectations of those who manufacture medical devices and other high-precision products.