Internal audits are an important activity for medical device manufacturers. They are not only a requirement for ISO 13485 compliance, but also an opportunity to get valuable feedback that can help to improve both the medical device and the development process. Oscar He is coordinating the internal audits that we at Key2Compliance are performing for our clients. Here he will tell you more about what the internal audit process looks, and how it can be a powerful tool for improving both the processes and make the medical device as safe and successful as possible.
Oscar He is Senior Consultant and Coordinating Manager for internal audits at Key2Compliance. With a background in medical biotechnology and with a lot of experience in medical device Quality Assurance and Regulatory Affairs, Oscar knows the ins and outs of the internal audit process.
While it’s not mandatory for medical device manufacturers to use an external third-party auditor, there are a lot of benefits in using outside help for the internal audits. “We can help the medical device companies audit themselves. It is recommended that manufacturers use an impartial auditor to get a better audit. As an external party, we have not been involved in the development of the device, and we can look at the processes with new eyes, bring a new perspective, and notice things that the manufacturer may miss. We also have a lot of experience in the medical device area, and with audits, so we can provide valuable suggestions on how to improve operations, make the process more efficient, and produce a device that is safe and that will be successful in the market.” says Oscar.
Key2Compliance help a wide array of companies with internal audits, from small one-person startups to larger international corporations, adapting to our clients’ needs. “We can design an audit that suits the company,” says Oscar, “A larger company may need two auditors over a couple of days while an audit for a smaller firm can be done with one auditor in a couple of hours. We also do supplier audits on behalf of the manufacturers. It is common to outsource critical processes such as manufacturing or sterilization to suppliers which needs to be audited as well. The goal is the same with all internal audits: to find any eventual deviations or parts of the regulations that have been missed, and to provide suggestions for improvement. We are not a regulatory body that is there only to point out problems, we are there to help and to show how the manufacturer can improve its operations.”
For Key2Compliance it is important to meet with our clients to get to know their company and its systems to deliver the best possible service. Since internal audits cover many different areas, we start by creating a plan for the audit. We map out which processes are going to be audited, and against which criteria are they to be reviewed. “The audit can take one or a few days, depending on the size of the company and how detailed the audit is. We usually start with a meeting where we ask questions to get a foundation. We look at everything from written procedures to calibration of equipment and have experienced internal auditors covering a wide range of special areas. If we find any deviations, we have a discussion and come up with suggestions for improvement. The audit itself is finalized with a written report, but we are happy to support the continuing work after the audit. We have a lot of experience improving processes and making them more efficient.”
There is no requirement that the manufacturer needs to use the same auditors again to check if the problems have been fixed, but according to Oscar it is a good thing to do as it creates continuity. “Following up on audits using the same auditor provides consistency and continuity. When the same auditor is returning, it is easy to compare the different parts of the process, how it looked like before, and what has been fixed. It creates a more efficient process with better insights.”
The current transition to the new EU regulations MDR and IVDR is affecting the internal audits in many ways. Oscar and his colleagues are aware that this can cause some concern among medical device manufacturers. “Right now, there are a lot of questions around the transitions and the new regulations. The main new requirements to keep in mind are Post-Market Surveillance, meaning the process of monitoring the safety and performance of a medical device after it has been released to the market and to follow up how it behaves when it is used. Then there’s the increased requirements for clinical data to support the safety and performance of medical devices. The MDR requires manufacturers to demonstrate the clinical benefits of their devices, including data on their intended use, the characteristics of the patient population, and the performance of the device. Another major new part of the MDR is Enhanced Requirements for Device Traceability, which mandates the use of a Unique Device Identification (UDI) system, and registration in the EUDAMED database.”
Oscar’s advice is to keep these changes and new requirements in mind, but to not let them overshadow everything else and relying on professionals to guide the way. “I know that MDR and IVDR are getting a lot of attention right now, but don’t forget the other new regulations and standards that are happening. For example, there’s a new directive establishing new cybersecurity requirements for medical device manufacturers. If you have any questions, just get in touch with us, and we will help you and give you advice. We are here to help and to make things simpler.”
It is common knowledge in the medical device area that internal audits are necessary, but according to Oscar it is not as well known that they can be performed by an external auditor, or what advantages that can have. “My advice is to not think of the internal audit as a box that must be ticked off. See it as an opportunity. Internal audits are good tools for reducing risks and for discovering what can be improved. By using an independent unbiased auditor, you will get feedback and support that you cannot give yourself. We have experience with many different clients, areas, and devices. If you use us as an external auditor, use the opportunity, dare to ask questions, and showcase how you work. This will help us to help you increase the quality of the processes and the products. See the internal audit as strategic, plan for it, and take advantage of the opportunity. We will help you in every way we can. And if you have any questions, just ask us.”
