Regulatory intelligence for medical devices

normScan – All your standards in one place

normScan is a web based monitoring tool for medical device standards. Tailored to your company portfolio, this software platform monitors all medical device standards (published and in development) that are relevant for your devices.

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Regulatory Advice and CE marking process support

Medical devices sold in Europe must bear the CE mark. CE marking is the manufacturer’s declaration that the device complies with the essential requirements of all the Directives that apply to it. It indicates to the European regulatory authorities and market that the product may be legally offered for sale.

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Authorized Representative Services (EC REP)

MDCPartners is an experienced European Authorized Representative – EC REP – for the IVD 98/79/EC and MD 93/42/EC directives. The European directives enforce the use of an Authorized Representative for manufacturers based outside the European Union.

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Regulatory and Standards Compliance Support:

Training in market awareness communications. Throughout the organization and in its interaction with distributors, a better understanding of the regulatory environment can greatly improve documentation compliance and speed to market. MDCPartners helps with coaching and training individuals and departments from RA/QA to commercial managers.

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