BioTop Medical is a well-established firm which provides regulatory affairs services to support medical devices companies to bring their products to the European and North American markets.
Our goal is to establish custom strategies to achieve and maintain regulatory compliance in a flexible and efficient manner. We support our clients with the development and implementation of tailored processes required to bring their products into the market and by providing hands-on management of the Regulatory Affairs and Quality Assurance activities. BioTop Medical builds long-term relationships with its clients ensuring in depth product and process knowledge.
OUR EXPERTISE:
• CE marking
• Quality Management Systems
• Risk Management
• Clinical Evaluation
• Literature Review
Company’s Keywords:
medical devices
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