As a medical device designer and manufacturer, Pathway Medtech is responsible for ensuring that the products we develop and create on behalf of our clients are safe and effective. One way we do this is by establishing and maintaining a quality management system (QMS).

A QMS is a set of policies, procedures, and processes that help you to control the quality of your medical devices throughout the manufacturing process. It covers all aspects of quality, from design and development to production and post-market surveillance.

The QMS maintained by your medical device development partner is crucial.  It will be used to assess the quality of your products and ensure that they meet all applicable regulatory requirements.

When you partner with Pathway Medtech, you can be confident that we have a robust QMS in place. We are ISO 13485:2016 certified, meaning that our quality management processes have been independently verified. We have decades of experience guiding Class I and Class II medical devices through design, manufacturing, and regulatory pipelines.

In fact, our expertise lies in assisting even the smallest companies and startups with their medical device design and manufacturing needs. We take on work larger companies refuse to consider.But our experience and willingness to accept complex challenges isn’t the only reason you should partner with us. We also offer:

* A focus on quality – We are committed to providing our clients with the highest quality medical devices possible. Our standards and certifications are a testament to this commitment.

* In-depth knowledge of regulations – We have a thorough understanding of the FDA’s Quality System Regulation (QSR), as well as quality standards such as ISO 13485. We can advise you on navigating the regulatory landscape and ensure your products meet all applicable requirements.

* A team of experts – Our team is composed of industry professionals who saw the “standard” way of doing things and thought Pathway could find a smoother, quicker path. One of the arenas in which we stand out is our adherence to true QMS and quality control principles.

* A comprehensive approach to quality – Our QMS is designed to cover all aspects of quality, from design and development to production and post-market surveillance. We can help you to control the quality of your medical devices at every stage of the manufacturing process.

Creating A QMS for Medical Devices

Creating a QMS can be daunting, but it doesn’t have to be. You can start by understanding the four basics of quality management systems and then building on that foundation.

There are four key elements to any quality management system:

#1: Quality planning

This is the process of identifying the quality standards that your medical devices must meet and planning how you will achieve them. It works by taking into account the requirements of your customers, regulatory bodies, and other stakeholders.

#2: Quality control

This is the process of ensuring that your medical devices meet the quality standards you have set. It includes activities like testing, inspections, and audits. It includes things like inspections, tests, and measurements.

Quality control activities are carried out at every stage of the manufacturing process, from incoming raw materials to finished products.

#3: Quality assurance

This is the process of ensuring that your quality management system is effective and efficient. It includes activities like monitoring and corrective action. It involves putting systems and processes in place to prevent problems from occurring and catching them if they do.

Some common quality assurance activities include design reviews, process audits, supplier audits, and product testing.

#4: Continuous improvement

This is the process of making continual improvements to your quality management system. It includes activities like root cause analysis and  corrective action. It involves constantly looking for ways to improve the quality of your medical devices and making changes to your processes and procedures accordingly.

Continuous improvement activities should be carried out on an ongoing basis, not just when problems arise.

When you partner with Pathway Medtech, we can help you with all aspects of quality management, from quality planning to quality assurance to continuous improvement. We have the experience and expertise to help you navigate the regulatory landscape and bring your medical devices to market quickly and efficiently. Contact us today to learn more about how we can help you.

Step-By-Step QMS Guide

Use this step-by-step guide to create a QMS for your medical device business:

[#1. Define your quality policy.

This sets the tone for everything that follows. Your quality policy should be a statement of your commitment to quality. It should be clear, concise, and easy to understand.

[H3] #2. Identify the quality standards you need to meet.

There are many different quality standards you may need to meet, depending on the type of medical devices you manufacture and the markets you sell them in. Some common standards include ISO 13485, 21 CFR 820, and EN ISO 14971.

#3. Establish quality objectives.

Quality objectives are specific goals that you want to achieve in relation to quality. They should be measurable, achievable, relevant, and time-bound. Examples of quality objectives could include “reducing customer complaints by X percent within Y months.”

#4. Implement your quality management system.

This will involve putting in place the systems and processes needed to meet your quality objectives. It should cover all aspects of your business, from design and development to manufacturing and marketing.

#5. Train your employees.

Your employees need to be aware of the quality standards you are trying to meet and how they fit into the overall picture. They also need to know how to use your quality management system effectively. Make sure you provide them with the training they need to do their jobs well.

#6. Monitor and measure performance.

You need to keep track of how well your quality management system is performing. This can be done through audits, inspections, and other monitoring activities. Make sure you take corrective action if any problems are found.

#7. Make continual improvements.

Your quality management system should always be evolving and improving. This can be done through activities such as root cause analysis and Kaizen events.

If you follow these steps, you will be well on your way to creating a quality management system that meets the needs of your medical device business. However, it is important to remember that a quality management system is never truly “finished.” It should be constantly evolving and adapting to meet the ever-changing needs of your business.

Other Tips For Medical Device Quality Management

Here are a few other tips to keep in mind when creating a quality management system for your medical device business:

– Make sure you involve all relevant stakeholders in the process. This includes employees, suppliers, customers, and anyone else who has a role to play in the quality of your medical devices.

– Keep your quality management system simple. It should be easy to understand and use.

– Be prepared to make changes to your quality management system as needed. It should be flexible and adaptable to meet the changing needs of your business.

– Make sure you have adequate resources in place to support your quality management system. This includes things like personnel, training, and financial resources.

Creating a quality management system can seem like a daunting task, but it is essential for any medical device business. By following the steps and tips outlined in this article, you can create a quality management system that will help you meet your quality objectives and bring your medical devices to market quickly and efficiently.

Pathway Medtech can be your expert source for all things medical device design and manufacturing, including FDA clearance and approval. Learn more about our work as designers and contract medical device manufacturers on our website. We’re proud to be a premiere medical device company here in San Diego, servicing biomed and healthcare businesses across Southern California.

If you would like to learn more about our quality management system or discuss your medical device development needs, please get in touch. Our team of experts would be happy to help.