Classical piano music is playing in the INCUBA office of Evnia CEO Efstathios Vassiliadis this morning.
From his office, he runs a cross-functional team of more than 60 medical writers, medical doctors, engineers, and biocompatibility experts across the globe who help medical device companies comply with regulations and bring novel solutions to patients in a faster and safer way.
In this sense, Evnia was almost designed to work through a pandemic. And as it turns out, COVID-19 is also creating a demand for their services from companies developing new products or converting existing ones into something that can be utilized to fight the pandemic.
"We have seen several companies try to capitalize on COVID-19 by using it as part of their marketing. But these claims need to be supported by evidence, which is something we advise clients about. We see it especially with products related to disinfection,” says Efstathios Vassiliadis.
A widespread issue
Evnia, which is Greek for ‘smart, articulate thinking’, specializes in clinical evaluation, regulatory and technical documentation and compliance management for medical devices and in-vitro diagnostics.
They help manufacturers bring new devices to the market and ensure that existing ones fulfill regulatory requirements. Which is not a given.
According to Efstathios Vassiliadis, many medical devices and in vitro diagnostics – some of which have been on the market for several years - lack actual clinical evidence to support their safety and performance claims or have gaps in their technical documentation. This also extends to big companies, he says.
Surging demand in wake of new regulations
Evnia was founded in 2016 on the brink of two new EU regulations (MDR and IVDR) addressing this issue by strengthening the rules on bringing new medical devices on the market and tightening surveillance and regulation of existing ones.
"The industry panicked. The new regulation drastically increased expectations to manufacturers and it takes a lot of resources and commitment to remediate this resulting in significant delays. This is where we come in," says Efstathios Vassiliadis, who gained deep insight in regulatory during his PhD-studies.
"One of our key specialties is clinical evaluation reports which were made mandatory in the EU in 2017. We compile, write, and find gaps in clinical evaluation reports, and have the setup to do post-market clinical follow-ups and clinical experience data creation. We cover the full spectrum."
Among the best in Europe
Since 2016 Evnia has completed more than 300 clinical evaluation reports for international life science companies. In December 2020, they were named one of the top compliance service companies in Europe by industry outlet Pharma Tech Outlook.
2021 is on the road to become another busy year for Evnia as the two EU regulations adopted in 2017 are being effectuated fully in May 2021 and May 2022, respectively.
"In 2021 we will be expanding further into generating data in support of performance and safety from clinical experience studies through our collaboration with hospitals and wide network of physicians of different specialities, which we will be publishing in peer review journals. The industry needs quality clinical data, and Evnia can deliver this."
Evnia offers full value chain services in Research & Development, Regulatory Compliance, and Management for pharmaceutical, biotechnology and medical Device companies and manufacturers. In January 2021 they announced a strategic partnership with Swiss company Qunique to better assist clients in the areas of regulatory affairs, quality management and pre-clinical/clinical documentation with an in-depth focus on the new EU Medical Device and In Vitro Diagnostics Regulations. The company was founded in 2016 by PhD and MBA Dr. Efstathios Vassiliadis who has a background in medical research from the US and the UK.
Find out more at www.evnia.dk