Alberto Turchi, Product Manager of Thema, answered some questions about his work and role, also giving us valuable advices. Let’s know him together…
How long have you been working in Thema and what exactly do you do?
I’ve been working in Thema for three and a half years. I have always worked in the operation sector dealing with active devices and software. In particular, I have specialized in drafting Technical Documentation and Medical Devices registration in the database of many European Countries. I currently hold the position of Product Manager, an assignment that is giving me the opportunity to follow from up close the clients and their devices.
What characteristics must a good consultant have?
First of all, a good consultant must have a good knowledge of the Regulations and the processes of Countries where the client’s Medical Device is to be marketed, knowing how to juggle best within the complex regulatory landscape. Also very important is the communicative aspect. As a big part of my role involves interfacing directly with the client, it is important to establish a synergy with the latter in such a way as to create a relationship of mutual trust. A good consultant, moreover, must be able to understand the needs of the person in front of him/her to find the best way to get the result.
What are the most frequent requests you receive from Clients?
One of the most frequent requests from my Clients is the drafting of Technical Documentation, in particular, Technical Documentation complies with Medical Devices Regulation (EU) 2017/745 (MDR), since May has taken place the important transition from CEE Directive 93/42 on Medical Devices to MDR (EU) 2017/745. This meant that many clients had to adapt their documentation to meet the new requirements. In particular, numerous modifications to the risk analysis sections of the device, clinical assessment and post-market surveillance have been made. So my workload is mainly focused on these sections.
What are the biggest challenges of the current regulatory scenario?
In recent years, the regulatory scenario has undergone profound changes, changing and introducing new specifications and requirements to be met. The most challenging aspect of the current regulatory scenario is not to be caught unprepared: you must always be ready for changes and keep up with the constant daily updates. It is also necessary to be curious to try to understand every single point of a regulation, rule or directive that is.
The best advice for your clients
The biggest advice I can give to my clients is not to be discouraged by the complex regulatory scenario. It is important to be ready for change and proactive, to grasp these updates as an opportunity for personal and professional growth and improvement. Difficulties represent an opportunity to maintain the quality of their work high and constant.
