Quality Assurance

Ensure your medical devices meet the highest standards of quality and patient safety, while adhering to regulatory requirements on an international level.

Expert Quality Assurance

Quality Systems

Enhance your medical device's quality and compliance while ensuring a safe and reliable product with our FDA-aligned quality systems.

QMS Compliance

Avoid costly non-conformances in manufacturing by using our comprehensive, compliant QMS.

QMS Remediation

Resolve FDA Form 483 or warning letter issues efficiently with our QMS remediation and ensure timely, effective compliance.

QMS Design

Streamline your organization's processes with our expert QMS design and implementation, following FDA, ISO, and MDSAP standards.

QMS Training

Empower your team with our QMS training that helps them understand roles and ensure ongoing compliance with evolving standards.

QMS Auditing

Optimize your quality management with a robust evaluation that verifies your compliance to specific audit criteria.


Hear From Our Happy Clients

Our clients’ experiences speak volumes about our commitment to innovation and quality. Here, you can read firsthand accounts of how Vantage MedTech has positively impacted various medical technology projects.
My relationship with Vantage MedTech spans three different companies and 15 years. I return to the Vantage MedTech team because they consistently deliver innovative solutions in a timely and cost-effective manner. I plan to continue this relationship for many years to come!
Vantage MedTech has provided us with a broad range of expertise, from electrical and software design to quality assurance and regulatory affairs. It would have been unlikely we could have hit our scheduled milestones without their help.
We were a young start up with a great technology, but were running into issues that our manufacturing partner could not explain. Over a year later and still no clear solution, I engaged Vantage MedTech to perform an independent analysis. Within 24 hours, they not only identified the issue, but also presented solutions to correct it. Vantage MedTech came forward with the level of expertise that was necessary to help turn around the situation, allowing REACT to bring our advanced neuromuscular therapy to patients who need it.
I have had the pleasure of working with Vantage MedTech team for the past seven years. The Vantage team is extremely professional, responsive, and collaborative. I know that I can always count on the Vantage MedTech Team to provide a quality product that will meet the product requirements.

Director of R&D

Several Medical Device & Life Sciences Firms


Katalyst Surgical

Kenneth C. Paulus

Founder & CEO, REACT Holdings & Pelvic Wave

Peter J. Oehlberg

Director, Technical Operations Bracco Diagnostics Inc

Rely on partners who can adapt to your needs, wherever you are in your journey

Our depth of expertise in specific clinical segments is strengthened by our dedicated team, refined processes, and specialized portfolio and proprietary platforms.

Years of experience
Specialized medical device engineers
On time delivery
Medical devices successfully developed
Experienced Partner

Reduce execution risk by working with a medical device software company known for over 1,600 medical devices successfully developed.

Advantage Platforms®

Leverage our proprietary platform architecture and reduce development timelines by up to 60%.

Expert Team Collaboration

Our in-house team of specialized engineers will bring your medical device from concept to reality with precision and care.

Need help with your medical device?

Let Vantage MedTech show how to bring your idea from concept to prototype to FDA/CE approval with a free custom project analysis.


Frequently Asked Questions

What is QMS For Medical Devices?

A quality management system (QMS) for medical devices is a structured system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.

It helps manufacturers consistently meet regulatory requirements and customer expectations for medical device products.

By focusing on risk management, design controls, and continual improvement, a QMS ensures the safety and efficacy of medical devices.

What is The Difference Between ISO 13485 & ISO 9001?

ISO 13485 and ISO 9001 are both standards for quality management systems, but they serve different purposes.

ISO 13485 is specifically designed for the medical device industry. It focuses on the safety and efficacy of medical devices. Requirements include regulatory compliance, risk management, and specific documentation for the design and manufacture of medical devices.

Comparatively, ISO 9001 is more general. It’s applicable to any organization seeking to improve customer satisfaction and process efficiency.

What Does QC Mean in Medical Technology?

In medical technology, QC stands for quality control. It refers to the procedures and processes used to ensure the quality and reliability of medical products and services.

QC involves the systematic inspection, testing, and verification of products and services to meet specific standards and requirements.

Quality control is vital in medical technology to prevent defects, ensure patient safety, and maintain regulatory compliance.

Does QA or QC Come First?

In the context of medical device manufacturing, QA generally comes first. It focuses on preventing defects in medical devices by ensuring processes and procedures are in place to produce quality products before development begins.

QC, on the other hand, occurs after the product is developed, but before it’s released to the market. It involves testing and inspection to ensure the final products meet the required quality standards.

Is ISO 13485 a QMS?

ISO 13485 is not a QMS in and of itself, but it is a standard used to govern QMSs. It provides a framework for companies to ensure consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

ISO 13485 is recognized internationally and is often required for regulatory purposes. Therefore, any medical device manufacturer’s QMS should be designed with ISO 13485 in mind.