While medical device companies can get caught up with processes and regulations, especially concerning ISO 13485, medical device companies are still businesses. And since they are businesses, they will have customers who purchase their products or services. In fact, ISO 13485 has an entire clause (7.2) dedicated to customer-related processes to ensure this aspect is … Read more
Change is essential and necessary for any organization, especially medical device manufacturers. Organizations need to be constantly aware of changes to materials, suppliers, processes, specifications, and other items related to their products. Not only are medical device companies required to be mindful of changes, but they must implement change control to maintain the function of … Read more
Controlling medical device monitoring and measuring equipment is an essential element of an ISO 13485 QMS. Monitoring and measuring equipment verifies that a medical device is safe to put on the market, so any issues with the equipment’s calibration can put patients at risk. For this reason, ISO 13485 section 7.6 should be approached with … Read more
It’s impossible to have a well-running ISO 13485 QMS without a good document control procedure. Not only will it leave your QMS open to undesired changes and gaps, but it can also lead to confusion and costly mistakes. Document control is also the area of a QMS where it is easiest to get findings during … Read more
A quality policy is the highest-level document for a medical device company. It is the star on the top of the Christmas tree, and the guiding light for a medical device QMS. So how does a company make one? If you are wondering how to make an excellent quality policy for your company, you’ve come … Read more
While many aspects of FDA and ISO 13485 quality system requirements can be found in other industries, Device Master Records (DMR) are something that is unique to medical devices. This can lead to confusion about what a DMR is, what is required, and how a DMR can best be integrated into a medical device quality … Read more
Management’s commitment to the quality management system is one of the key principles of ISO 13485. One of the ways management’s commitment is demonstrated is through management reviews (ISO Clause 5.6). While management review is frequently seen as a box to check to meet ISO 13485 requirements, if properly executed, it can be a powerful … Read more
Are you struggling to ensure your training program meets ISO 13485 training requirements? You’ve come to the right place. This article will cover all of the ins and outs of the Human Resources section (6.2) of ISO 13485:2016, and provide a complete guide to creating a compliant training procedure. Training is one of the most … Read more
Have you implemented an ISO 13485 compliant training system, but are still struggling to determine how to evaluate the effectiveness of training actions? You’re not alone. The effectiveness aspect of ISO 13485 clause 6.2 is something that causes the most difficulties when implementing a medical device QMS. You know your employees are trained and management … Read more
A medical device company’s complaint handling system is one of the most essential elements of its quality management system. A bad process will leave the company with an increased likelihood of audit findings, and present the company with possible legal and regulatory consequences. A good ISO 13485 complaint handling process can lead to increased customer … Read more