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Regulatory compliance expert Metecon establishes its Swiss subsidiary in Bern

Medical device regulatory compliance provider Metecon has opened a subsidiary in Bern, offering on-site support in Swiss and EU markets.

Marco Scicolone (to the left) and Alexander Fink (to the right) are looking forward to working together.
Marco Scicolone (to the left) and Alexander Fink (to the right) are looking forward to working together.

 

Metecon Switzerland LLC, a sister company of the German Metecon GmbH, is pleased to announce its launch in Switzerland as a medical device regulatory compliance service provider. With this move, Metecon will offer its Swiss customers reliable and competent on-site support: for the marketing and post-marketing surveillance of their medical devices and in vitro diagnostic (IVD) products, both in the Swiss/EU markets, and worldwide.

By deciding to expand into this country, Metecon Switzerland aims to meet the needs of both local medical device and IVD manufacturers as well as EU manufacturers: “Switzerland is an important market for the medical technology industry, and medical devices and IVDs entail difficult regulatory compliance for which expertise and experience are required,” explains Alexander Fink, owner and managing director of Metecon. “Through our local presence, we can offer our customers in Switzerland personal support and customized solutions; As a Swiss agent (CH-Rep) with Metecon Switzerland LLC, we quickly and efficiently open the way to the Swiss market for EU manufacturers.”

The Swiss sister company, in the same way as Metecon GmbH, offers all regulatory services throughout the entire product life cycle: from the preparation and adaptation of technical documentation to support in clinical evaluation or performance assessment, from the planning and implementation of post-market surveillance to consulting and knowledge transfer with regard to current regulatory requirements – Metecon Switzerland is on hand to provide comprehensive know-how.

Marco Scicolone will be responsible for Business Development at the new location and will therefore be the contact person for all customers of Metecon Switzerland. “Our mission is to be a fast and reliable navigator for our customers through the complex compliance process, ensuring smooth market access and minimizing costs and risks,” Marco Scicolone emphasizes. “We offer customized solutions tailored to the specific needs of our clients. Our extensive industry knowledge and deep understanding of Swiss and (extra-)European regulations make us the ideal partner for manufacturers.”

In doing so, Metecon Switzerland places emphasis on close cooperation with its customers: “We strive for long-term partnerships and offer excellent services at the highest level,” emphasizes Alexander Fink. “The expansion into Switzerland is another milestone for Metecon and underlines our commitment to provide first-class regulatory compliance solutions to our customers worldwide.”

GGBa and the Bern Development Economic Agency have supported the process of creating the Metecon’s new entity, allowing the subsidiary to start its activities in Switzerland as quickly as possible.

About Metecon:

Metecon is a leading service provider for regulatory compliance of medical devices and in vitro diagnostics. With extensive expertise, almost 25 years of experience and more than 60 permanent experts, Metecon supports its clients in meeting all regulatory requirements: from the Quality Management System to Technical Documentation and Clinical Evaluation to Post-Market Surveillance (PMS). With locations in Germany and Switzerland as well as dedicated Representative Services – such as the European Representative, who represents manufacturers e.g. from Switzerland in the EU, and the Swiss Representative, who represents EU and international manufacturers in Switzerland – Metecon offers tailor-made solutions worldwide.

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