MediTech Strategic Consultants B.V.: European Medical Devices Market Authorization (CE MARK)

MediTech Strategic Consultants B.V. (MediTech) is full service European Contract Research Organization (CRO) specializing in medical devices and combination products focused on Clinical, Regulatory and Quality consulting as well as Authorized Representative Services. MediTech’s headquarters office is centrally located in Vaals, in the south of The Netherlands, close to the German and Belgium borders. The company specializes in bringing medical devices CE Mark approval, via regulatory consulting and clinical trials as well as post marketing studies/registries after having obtained CE Mark.

MediTech, which operates clinical trials throughout the European Union, Israel, Norway, Switzerland and Turkey, was founded to fill a need that was lacking in the market for CRO services for medical devices and small entrepreneurial companies, in addition to offering companies the full range of necessary services: Regulatory, Quality, Clinical and Authorized Representative. Roy Lohmann, Business Controller and a member of the Senior Managament team of MediTech, notes that the more well known, larger CROs tend to service larger companies and were pharma driven, despite a large number of smaller companies that need this support, and have the opportunity to succeed in the market.

Further, “MediTech understands the entrepreneurial culture,” says Roy Lohmann, and “can customize proposal’s to tailor smaller companies’ special needs.” MediTech’s broad network of key opinion leaders and access to leading European clinical sites further differentiates MediTech from other CROs in this space.

MediTech, a sponsor of OneMedForumNY 2012, conducted a management interview at the conference. In the interview, Lohmann discusses why the European market is particularly enticing for smaller commercialization-stage medical device companies.

As a CRO specializing in and focused on medical devices and combination products, one of MediTech’s key objectives is to assist clients in placing new medical devices and combination products on the European market. The MediTech team consists of over 40 highly experienced individuals qualified to provide clinical, regulatory, and quality guidance and project support. Their medical technical expertise is complemented by multilingual and cross cultural fluency.

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