Medical Devices

In addition to our public and on-site ISO 13485 courses, we can now assist medical device companies in bringing their products to market. Our engineers can conduct risk assessments, perform mechanical test design and execution, trouble-shoot products, and help implement quality management systems.

Risk Assessment

Why do a risk assessment on your medical device? Because it is a legal requirement of GMP 21 CFR Section 820, and reduces liability by finding flaws. The risk assessment should be the basis of both clinical and non-clinical testing. And, it is the right thing to do for the patient.

Mechanical Test Design and Execution

A regulatory submission may require a series of non-clinical tests. Factors such as strength, fatigue, wear, and failure are common characteristics that need to be determined for new products. The design of these tests is often straight-forward, but in some cases, a new device brings new testing challenges. Our engineers have extensive experience in bench-top and animal testing experiments. Doing the right testing the first time saves time and money.

Product Design and Evaluation

Part of designing a safe and effective medical device is trouble-shooting either design or product issues when a device is not functioning as needed. Our evaluations have helped medical device companies improve their design before and after a product has gone through the regulatory track. With our team of engineering experts, and the added benefit of being unbiased external examiners, we often see improvements and modifications that are not obvious to vested team members who have always been part of the design group. Having a “new set of eyes” on a design problem can lead to significant enhancements in the product’s performance, as well as, reduce risks for the current device.

Quality Management System Before your company can start manufacturing a medical device, you must have a quality system in place. Our engineers have designed and implemented tailored quality systems for medical device companies that meet the specific needs of the client. We know quality systems can be cumbersome if not done right, so we work with your needs to make you compliant without burdening your organization with unnecessary paperwork.

We have extensive experience with implementing 21 CFR Part 820, GLP, ISO 13485, ISO 14971, MDD, and CMDCAS. Our engineers also have experience performing regulatory audits of vendors and gap analysis of quality systems for start-up medical device companies.