QMS for Medical Device Manufacturers

QMS for Medical Device Manufacturers

Transform your medical device manufacturing with our cutting-edge product, designed to streamline processes and optimize quality while adhering to industry regulations.

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Challenge

Regulatory compliance & process efficiency

Struggling to maintain regulatory compliance? Our product ensures adherence to global standards while simplifying complex processes, saving you time and resources. Want to boost efficiency? Our innovative solution optimizes workflows, empowering you to focus on what truly matters: delivering exceptional medical devices.

Solution

Enhance efficiency & ensure compliance

Experience the power of a comprehensive Quality Management System (QMS) that streamlines your operations and keeps you compliant in a demanding industry landscape.

Quotes

We’re confident that Intellect will continue to serve us well as we automate our systems even further. Intellect is enabling us to add tangible business value for Klean Kanteen.

Joshua Birkle, Klean Kanteen

Quotes

With the help of Intellect, we have been able to successfully automate our document control and supply chain processes, which has enabled us to strengthen quality and compliance.

Nazia Khan, Fluid Metering

Quotes

We needed software that could provide a strong foundation for QMS but could also be adapted quickly and easily to meet our unique needs. Intellect provided the perfect blend of what we were looking for.

Ken Hankins, Vornado

Streamline processes, optimize quality, and ensure compliance

Empowering medical device manufacturers

Audit Management

Streamlined audits for enhanced compliance

Efficiently manage and execute audits with our robust audit management feature, which minimizes time spent on paperwork and reduces the risk of non-compliance, keeping your company on track and compliant.

Simply your audit process
CAPA

Effective corrective and preventive action

Implement corrective and preventive actions easily, ensuring that your medical device production stays on course and meets the highest quality standards, ultimately improving patient outcomes.

Automate your CAPAs
Device History Records

Ensure regulatory compliance

Record production data, track nonconformances, and verifythat all devices meet approved specifications. With centralized and digitized records, you can minimize manual errors, reduce operational costs, and improve overall efficiency.

More on DHR
Document control

Organized and secure document management

Effortlessly manage and access critical documentation with our secure document control feature, ensuring that your company operates with the most up-to-date information and maintains regulatory compliance.

Organize your documents
Employee Training

Your Training Co-Pilot

Track your developmental processes, improve employee training oversight, and achieve your compliance goals.

Train Better
Nonconformances

Customize NCRs and Trigger CAPAs

Control steps, approvals, notifications, and all nonconformance actions. Escalate and trigger a CAPA

More about NCR
Validate & Verify

Establish and maintain process for different types of validation

Establish and maintain process for different types of validation. The workflow helps to automate and streamline the process for identifying, defining, creating plans, test scripts and execution activities.

More on V & V

Resources

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Intellect LogoWhat to Look for When Selecting a QMS for your Medical Device Company
Blog
What to Look for When Selecting a QMS for your Medical Device Company
03 April, 2023
Quality is critical in the medical device industry. Therefore, medical device companies must comply with regulations, st...
Intellect LogoHow to Set Smart Goals and Objectives in Quality Management Systems
Blog
How to Set Smart Goals and Objectives in Quality Management Systems
11 January, 2023
Setting SMART quality goals and objectives with clear documentation is critical to all companies.
Intellect LogoPromoting A Quality Culture Within the Workplace
Blog
Promoting A Quality Culture Within the Workplace
22 December, 2020
Ask any business executive whether the quality is important, and you’re likely to get a very quick response: “Absolutely, it’s one of our top priorities.