Nexialist: The Compliance Experts

Entrepreneurs invest a significant amount of time and resources in strategising and planning while building a business from the ground up. However, not many can realise the importance and enormous role of a business name that truly transpires their perception and sums up everything that their company is about. The folks at Nexialist beg to differ, who were inspired by the term ‘Nexialist’—long known to describe someone who has trained in “interdisciplinary science and thought.” The name—first coined by Alfred Elton van Vogt, a Canadian-born science fiction author—is typically used for someone who can see the connections between different disciplines that others cannot see, seasoned in conflict resolution, and can seamlessly solve complex problems as a great link builder within a team.

It’s no coincidence that Vincent Castéras, Associate Director of Nexialist and his team decided upon this particular business name to pursue their vision and mission. Since its inception in 2006, the company has been committed to one goal: develop and provide market access to medical innovations, using a multidisciplinary approach based on a global view of the product life cycle that includes the end-user.

As the name suggests, Nexialist—skilled in joining the knowledge of one field of learning with that of other areas to find original solutions to problems and identify new tracks— was born to empower companies in the medical device sector, including in vitro diagnostic and advanced therapy devices. Today, the company is well-positioned in Europe as a key player in medical consulting, helping its clients solve diverse compliance, quality, and regulatory-related challenges as well as build product development and commercialisation strategy.

According to Castéras, the focus is on bringing high-quality medical devices and in-vitro diagnostics to the market. “When it comes to medical devices or in vitro diagnostics, I always wanted my family and friends to get the best products possible. As a result, me and my team at Nexialist decided to be a part of the process of such products. This is precisely when we observed a market gap—the lack of seamless communication between the regulatory authorities in Europe and manufacturers, importers, and distributors,” he explains. The biggest problem concerning compliance and conformity is the misunderstanding or difficulty of communication between these two parties. “We stand literally between the twoto help manufacturers talk to regulatory authorities, and regulatory authorities to understand what the manufacturers are expecting or trying to do.”

He goes on to mention that more than 80 per cent of the in vitro diagnostic products nowadays are on self CE marking— an auto CE marking system where the manufacturer reads the directive, sets up a system as per his understanding of the directive and a technical file, before putting the products on the market with a CE mark on them.

The challenge here lies in transitioning from 80 per cent self-certified products to 80 per cent of the products that meet the requirements of the regulatory bodies. However, this transition is faced with two main roadblocks. First off, the lack of notified/regulatory bodies under the IDVR. While the amount of self-certified products continues to grow, there are not as many notified/regulatory bodies to review them.

Entrepreneurs invest a significant amount of time and resources in strategising and planning while building a business from the ground up. However, not many can realise the importance and enormous role of a business name that truly transpires their perception and sums up everything that their company is about. The folks at Nexialist beg to differ, who were inspired by the term ‘Nexialist’—long known to describe someone who has trained in “interdisciplinary science and thought.” The name—first coined by Alfred Elton van Vogt, a Canadian-born science fiction author—is typically used for someone who can see the connections between different disciplines that others cannot see, seasoned in conflict resolution, and can seamlessly solve complex problems as a great link builder within a team.

It’s no coincidence that Vincent Castéras, Associate Director of Nexialist and his team decided upon this particular business name to pursue their vision and mission. Since its inception in 2006, the company has been committed to one goal: develop and provide market access to medical innovations, using a multidisciplinary approach based on a global view of the product life cycle that includes the end-user.

As the name suggests, Nexialist—skilled in joining the knowledge of one field of learning with that of other areas to find original solutions to problems and identify new tracks— was born to empower companies in the medical device sector, including in vitro diagnostic and advanced therapy devices. Today, the company is well-positioned in Europe as a key player in medical consulting, helping its clients solve diverse compliance, quality, and regulatory-related challenges as well as build product development and commercialisation strategy.

According to Castéras, the focus is on bringing high-quality medical devices and in-vitro diagnostics to the market. “When it comes to medical devices or in vitro diagnostics, I always wanted my family and friends to get the best products possible. As a result, me and my team at Nexialist decided to be a part of the process of such products. This is precisely when we observed a market gap—the lack of seamless communication between the regulatory authorities in Europe and manufacturers, importers, and distributors,” he explains. The biggest problem concerning compliance and conformity is the misunderstanding or difficulty of communication between these two parties. “We stand literally between the twoto help manufacturers talk to regulatory authorities, and regulatory authorities to understand what the manufacturers are expecting or trying to do.”

He goes on to mention that more than 80 per cent of the in vitro diagnostic products nowadays are on self CE marking— an auto CE marking system where the manufacturer reads the directive, sets up a system as per his understanding of the directive and a technical file, before putting the products on the market with a CE mark on them. The challenge here lies in transitioning from 80 per cent self-certified products to 80 per cent of the products that meet the requirements of the regulatory bodies. However, this transition is faced with two main roadblocks. First off, the lack of notified/regulatory bodies under the IDVR. While the amount of self-certified products continues to grow, there are not as many notified/regulatory bodies to review them.
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A key player in medical consulting, helping its clients solve diverse compliance, quality, and regulatory-related challenges as well as build product development and commercialisation strategy

Nexialist