Medical Device Tolerance Verification: Ensuring Precision and Quality

In the medical device industry, precision and accuracy are paramount. Tolerance verification plays a crucial role in ensuring that medical devices meet stringent regulatory standards and function as intended. At Made to Measure Metrology, we offer comprehensive medical device tolerance verification services to help you maintain the highest quality standards.

Our Tolerance Verification Services

Dimensional inspection: Accurate measurement of critical dimensions to ensure compliance with specifications.
Functional testing: Verification of device performance under simulated conditions to identify any deviations.
Material analysis: Evaluation of material properties and composition to ensure suitability for medical applications.
Regulatory compliance: Assistance with navigating complex regulatory requirements and standards.

The Importance of Tolerance Verification

Patient safety: Accurate tolerance verification helps prevent medical device failures that could compromise patient safety.
Regulatory compliance: Adherence to tolerance standards is essential for obtaining regulatory approvals and market access.
Product quality: Consistent tolerance verification ensures that medical devices meet the expected level of quality and performance.
Cost-effectiveness: Preventing product recalls and rework can significantly reduce costs associated with quality issues.

Our Process

Consultation: We work closely with you to understand your specific requirements and identify critical tolerance parameters.
Inspection and testing: Our skilled technicians utilize advanced equipment to perform precise measurements and functional tests.
Data analysis: We analyze the collected data to identify any deviations from tolerance limits and provide detailed reports.
Corrective actions: If necessary, we recommend corrective actions to address any quality issues.

Our Expertise

Industry knowledge: Our team has extensive experience in the medical device industry, understanding the unique challenges and requirements.
State-of-the-art equipment: We invest in the latest metrology technology to ensure accurate and efficient measurements.
Quality assurance: Our commitment to quality is reflected in our adherence to rigorous quality control standards.

Made to Measure has been inspecting medical parts, devices, equipment and components for over 35 years. We not only have a vast array of equipment, but a team of Metrologists unrivaled in the industry. Read more about our dedication to the medical manufacturing industry and how we can support you.

ISO Accreditations/ASME Certifications

Made to Measure supports and understands ISO13845 requirements. Made to Measure’s ISO accreditations include ISO 17025 for dimensional measurement and ISO 17025 for dimensional calibration. Additionally, our senior level Metrologists are ASME GDTP certified, the highest level of proficiency in geometric dimensioning and tolerancing principles offer by the American Society of Mechanical Engineers.

Form, Function, & Comfort

With most components, form and function is the only concern. With medical devices, we appreciate the special requirement to perform comfortably as well. We fully grasp that the importance of the dimensional inspection and analysis performed holds an extra level of urgency. That’s why we take extra care to make sure the inspection data is right and meaningful.

Special Handing Requirements

When requested, Made to Measure Metrologists will handle and inspect medical components with any required PPE including gloves, masks, face shields, and protective suits. Non-contact inspections are also available. In addition to our stable, climate controlled laboratory conditions, our staff can take extra precautions to eliminate contaminates from the environment by creating a temporary cleanroom.

Transparency of approach, process, and accuracy

Whether we are working with a medical components manufacturer or an aerospace company, Made to Measure automatically documents and shares how we capture the data in your report and provides traceability. From the Metrologists who worked on your project to the equipment used, we are fully transparent. We are open to adopting special reporting formats, following prescribed inspection processes, and using custom fixturing. If you would like to be at Made to Measure to observe the inspection of your components, we are happy to accommodate you and any colleagues you would like to attend. If you can’t attend, but would like to see the inspection, we can set up a camera or send video or pictures.

We Inspect All types of Medical Components

We are fully aware that not all medical components are the same. That’s why we have some many tools in our lab to inspect your components. We can inspect nearly any size, weight, or material and can handle complex geometries and super tight tolerances. We have at our disposal a wide range of CMMs, vision machines, CT scanners, laser scanners, and manual hand tools. Whatever you need inspected, we’re confident we can support your project.

Industry-Leading Metrologists

We have some of most experienced and well-trained Metrologists in the industry. They come from very diverse backgrounds ranging from plastic injection molding to machining. Our Metrologists have worked on thousands of projects involving most medical applications. We believe that with our experience, education, and training, we can provide you the best inspection service available.

Consulting & Training

When requested, our Metrologists take their expertise beyond the inspection of components by offering our clients consulting and training. We can review your drawings and make recommendation on how to best modify them or develop a new inspection process that you can take back to your lab. We also provide metrology training to medical companies across North America to help them enhance their metrology competencies. Whether you’re looking for consulting support or metrology training, please consider Made to Measure.

Fast Lead-Times/ Expedited & Emergency Service

Made to Made on average has 13 Metrologists on staff full-time. We can handle large influxes of inspections. When necessary, our team will commit more time to provide 2 to 3 day expedited service or 1 day emergency service.