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BioTop Medical has been dedicated to regulatory compliance and quality assurance projects, for many companies involved with medical devices. These companies are either active in the development, production, sales of devices or all of these activities.

Our clients range from small start-up companies focused on the development of innovative products to the trading companies, marketing products developed by other firms. Our clients are also large multinational companies in need of additional expert advice or of additional “hands” for their regulatory department.

We help our clients to achieve regulatory compliance for a broad range of products; from the simple Class I medical device to the Class III device with or without animal derived or medicinal substances. We have experience with active and non–active devices, borderline products and in vitro diagnostic devices.

For direct contact call +31 (0)71 528 01 12