Approval as a medical product

As a manufacturer of medical products, we are intimately familiar with the approval conditions for medical products. So that you can completely concentrate on your core competences, we will stand by you as an expert partner for all approval matters. We will help you put your product into circulation and will prepare it for approval for national and international markets. We have already had several products approved for the American market in accordance with 510 (k).

Our services:

• Consulting on approval-specific questions for product development
• Standard and patent research
• Creation of technical documentation and review of existing documents
• Support in the areas of risk management (DIN EN ISO 14971), the SW development process (DIN EN ISO 62304) and usability (DIN EN ISO 62366)
• Drawing up of accompanying documents
• Communication with test labs and notified bodies
• Check for compliance with the fundamental requirements of the medical product law (MPG)
• Drawing up of approval applications