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Germany based EU Authorized Representative "mdi Europa" helps small to medium sized manufacturers to enter european medical device market.

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Provides CE marking, quality management system implementation and auditing of ISO 13485, (pre)clinical evaluation, product market approval (e.g. CE/EU and FDA/USA) and production registration as well as other regulatory services.

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This coalition, composed of members of the Dallas District FDA Staff and individuals from associations representing the medical device industry , was formed to promote communication, education and cooperation between the regulators and the regulated industry. To further these goals, the coalition holds quarterly meetings to discuss issues of concern to the regulation of medical devices. ...

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EU MDR - Regulation (EU) 2017/745

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Litigation encompassing construction defects, fraud, insurance disputes, personal injury, products liability, and environmental matters. Attorneys, profile, client list, and contacts.

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Provides training and consulting services in software quality control. Details of training and workshops available are included.

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Analysts and consultants specializing in document and knowledge management.

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