Miriam Cangi, Project Manager of Thema, answered some questions about her work and role, also giving us valuable advices. Let’s know her together…

What is your role at Thema?

At Thema I play the role of Project Manager. Specifically, I am in charge of the operational management of a job order, starting with the definition of the execution strategy and ending with the delivery of the final result to the customer.

What do you like most in your job?

It is never a monotonous job. Each activity is different from the previous one. The rules are the same for everyone, but each case is different. I like to empathise with the realities of each individual customer and help them overcome every obstacle. Every day is full of new challenges and this is very stimulating for me.

What studies and experiences have brought you this far?

I obtained my Master’s degree in Biomedical Engineering at the Polytechnic University of Turin. I gained my professional experience in the regulatory sector first of all while carrying out my Master’s thesis, through the drafting of the Technical Documentation of an innovative Medical Device for non-invasive ventilation according to the MDR Regulation (EU) 2017/745. Subsequently, I carried out consulting activities in the strategic-regulatory field by supporting my Clients in the preparation of technical files for the CE marking of Medical Devices and in the adaptation of QMS processes to the MDR.

What qualities make you a good consultant?

My predisposition to actively listen and discover my client’s true needs, focusing especially on the unspoken or not explicitly expressed.  But also my focus on professional growth, my willingness to learn new things and the need to constantly improve what I do.

What are the main needs of customers?

These days I receive many requests regarding the extension of the MDR, published in the Official Gazette on 20 March 2023. Manufacturers ask me whether the extension of the transitional period in Art. 120 MDR (EU) 2017/745 applies to them. Although many may benefit from the extension, my advice is not to wait and to start the adaptation process now, given the complexity of the activities and steps involved in the EC certification process. In addition, I often receive requests for support from European manufacturers who want to enter non-EU markets, among others, the US one stands out.

Which nonconformities do you detect most frequently among your customers?

I often come across the absence of a Quality Technical Agreement (QTA) between Economic Operators in the context of the MDR Regulation (EU) 2017/745. This agreement is of crucial importance as it establishes the responsibilities of the different parties involved in the activities. These could have a direct impact on the quality, safety and efficacy of Medical Devices once they are placed on the market.  A recurring nonconfomity is the absence of the necessary documentation to describe the design and manufacturing process of a Medical Device as required by Annex II of the MDR.

The best advice for your customers

Be open to change: the only way to keep up with the ever-changing regulatory world in the medical sector. Also, as I have already said, be proactive: don’t wait to apply for consultancy as the times and processes in Quality and Regulatory are particularly complex.