Talyta, let’s start with a small introduction. Could you tell us something about yourself and your background?
I am a medical device professional with R&D and regulatory background and over 10 years’ experience in the field of Medical Devices, combining a technical background with a fulfilling career in the areas of devices design and development, regulatory affairs and quality management systems and leading people.
I have also a Bachelor of Engineering, a Master´s Degree in Biomedical Engineering and I have worked as MD manager and Chief Auditor.
My experience spans multiple specialties, including software as medical device, orthopedic devices, surgical navigators, minimally invasive surgery, neurostimulation and self-testing IVD.
What is your main area of expertise?
My expertise is specially related to the Quality Management Systems development and implementation, and the medical device European regulatory approval.
Could you tell us about your experiences before joining Asphalion?
In the past 10 years, I had the pleasure to enjoy some time with several different type of devices and activities. For example, at the beginning of my career as project engineer, I developed some neurosurgery and orthopaedic devices. After that, I joined the fascinating quality and regulatory affairs world, where I had the opportunity to participate in the certification processes of IVD self-testing device and medical device software.
Do you think that the new remote work model will affect quality assessment procedures, such as internal or notified body audits?
It is a possibility, although the technology allows us to be close and in a fast manner certain details can be lost during a remote audit. Not all details can be seen and that can make the audit more complicated.
The European Commission published an important information about remote audits by the Notified bodies, and they reinforce that as soon as possible, of course observing all current sanitary restrictions, on site audits should be preferably carried out.
Which are the trending topics at the moment in MD?
Probably medical device software, with the rapid advancement of technology. Artificial intelligence and new apps are developed daily but, unfortunately, as happens in all other technological fields, the legislation is not able to keep up with these advances so quickly.
How do you stay up to date with everything that is happening in the MedTech-world?
Be up to date about absolutely everything is, of course, impossible, but I keep my eyes open on social media, specialized magazines and papers and, especially on university publications, where there are always good ideas to be found.
What is your experience in the challenges of quality for MD?
Developing and implementing a quality management system in a start-up company is a big challenge that I have had the pleasure to experience more than once. Adapting the ISO 13485 and the European requirements for a small company is challenging, but with dedication and patience it is possible.
What can you tell us about QMS as a new MD service from your perspective of Medical Device Manager/ certified Lead Auditor?
We have started this new and thrilling service to help companies to comply with the most demanding regulations and standards. At Asphalion, we can help companies to develop a tailored quality management system from scratch, update procedures, work instructions or templates. We can also perform internal audits or help companies with their management review meetings, among many other things.
Having been in the manufacturer’s side gives you a very accurate overview of what really means developing a medical device. Now that you are in the consulting side, would you like to give any special advice to our customers? Something you would like to share for them to be aware of?
I would tell them to really think in the quality and regulatory affairs at an early stage, since it is very important to be able to develop the product in a regulated, organized and documented environment. This can prevent future headaches!
We would like to thank Talyta for her time!
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