2022 is a special year for us at Thema, as it is our company’s 15th birthday.
After many years of looking far and wide in the wake of incredible growth, this is an opportunity to pause for a moment, look back and retrace the steps that, through many accomplishments, brought us here.
Thema was born in July 2007, and it already had a strong specialization in the creation of technical documentation and management of international regulatory activities in the field of Medical Devices and IVDs. The young Marisa Testa is the creator of this original, indeed unique project, which immediately draws attention to itself and receives significant awards.
Just one year later, in 2008, Thema is awarded with the first prize at “Progettando”, a competition in the province of Bologna (Italy) which rewards innovative business ideas from young aspiring entrepreneurs.
In 2010, while orders, customers, and co-workers grew more and more, Marisa Testa, the founder of the company, is awarded with the Young Entrepreneurs Prize as part of the 1st Bologna Chamber of Commerce Youth Entrepreneurship Forum.
In 2011, Thema achieves another important success: its Quality Management System obtains ISO 9001 Certification for the provision of national and international regulatory services, quality system certification consultancy in accordance with ISO 9001, ISO 13485, and GMP, product certification consultancy, and drafting of technical documentation for companies in the medical sector.
In the same year, Thema receives an honorable mention at the OPTA competition as part of the ICT Gender – Innovative Creative Technology.
In 2012, just 5 years later its foundation, Thema shows its full vocation, now well defined, by specializing in strategic and regulatory consultancy services in the medical field, to provide support to companies in the sector wishing to market their own Medical Devices in compliance with regulations.
Alongside strategic regulatory consultancy, the desire to disseminate and create regulatory culture developed. So, there you go, in November 2013 MD24 was born. It provides highly specialized training courses for professionals working in the Quality & Regulatory field of Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVDs) sector, offering high value training courses, seminars, and webinars, keeping pace with evolving regulatory scenarios.
Starting from 2015, MD24 organizes an annual event in October, the MDG – MedGenerAction event, a true point of reference for professionals dealing with regulatory activities applied to Medical Devices. Thanks to MDG, participants have the opportunity to exchange experiences and to gain skills with the contribution of the most important stakeholders and the most leading experts in the field, in a relaxed and exciting networking atmosphere. The MDG event is indeed an opportunity for information sharing, updating, and discussion.
In February 2017, to establish itself ever more strongly in the medical sector as an example of excellence in the management of regulatory processes, Thema achieves ISO 13485 certification for the provision of national and international regulatory services, Authorized Representative services for Europe, Regulatory Correspondent services for Canada, US Agent services, Contact Person, and regulatory referent for the US, product certification consultancy and drafting of technical documentation for companies in the medical sector.
In November 2019, the MD24 company is transformed into a Brand to optimize the services provided, which are increasingly focusing on high-level training using the expertise of Thema experts. In February 2020, aware of the crucial importance of excellent training for professionals working in the sector, Thema obtains the extension of ISO 9001 and ISO 13485 certifications to the planning and delivery of training events for the medical sector.
Finally, last year in April, the Group CompLife Italy acquires Thema. This acquisition enables Thema to consolidate its position in its sector and to face new opportunities by becoming part of a major international player. Joining CompLife Group therefore responds to THEMA’s desire to further expand its horizons in the field of Health & Personal Care, in line with its mission: Let’s take care beyond the boundaries.
Hereby, in these 15 years important goals have been achieved, it has been 15 years of choices, changes, constant commitment, and a lot of satisfaction. For this reason, we would like to consider this anniversary as the first step of the path that Thema decided to take, with the belief that there are many more to come, while maintaining the same enthusiasm and motivation that have driven us from the beginning and allowed us to get this far.
We would like to say a special thank you to the companies that have believed in us over the years and have made us part of their success. Finally, thank you to our partners, employees and all those who have contributed to making this important milestone possible.
Now, we look forward with enthusiasm to the future and to continuous improvement in order to keep offering new opportunities and excellent services.
Marisa Testa – CEO, Product Manager, QA/RA Thema Consultant .