Anyone trying to introduce a medical product into the marketplace quickly encounters a daunting maze of laws, standards, and national and international regulations. Would you like to have a competent partner who is familiar with the flood of regulations on the way to CE certification? Someone to whom you can delegate tasks and who will help you reduce your overhead costs? As an integrated component of our service portfolio, we take these tasks on for you and help you satisfy the market access requirements.
Our regulatory affairs specialists prepare technical documentation in collaboration with product development, quality management, marketing and the customer. This provides a full description of your products. From the first idea up to CE certification or registration, only with proper, conforming documentation may the product be legally sold.
In addition to product-specific descriptions, the technical documentation contains among other things a comprehensive risk assessment and details regarding the suitability for use.
The clinical evaluation is also part of the documentation. It is prepared in accordance with MEDDEV or GHTF specifications. sfm has an extensive network of qualified experts with product-related and medical know-how at its disposal to prepare these clinical assessments.
As a provider of integrated medical technology solutions, sfm offers its customers a complete package of services — even in the realm of Regulatory Affairs. From the very beginning, we help you along the path to the successful marketing of your products.
