Our team has a broad range of experience, including product design and development, manufacturing, sterilization, and product testing.
Our wound and skin care technical specialists are product experts who understand the specifics of these complex medical devices. The team has an average of over 15 years’ industry and regulatory experience. We are highly trained in working with wound and skin care device manufacturers who specialize in a variety of fields, including acute, chronic and infected wounds, burns, dermatology, ostomy, surgical intervention, trauma and wound closure.
In addition, we can provide guidance on wound and skin care combination products that incorporate medicinal components, ranging from known medicinal substances, such as iodine, PHMB and silver, to more complex and borderline medicinal substances. We have a proven track record of successful consultations with many competent authorities and the European Medicines Agency (EMA).
BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. It is critical to work with an EU notified body or UK approved body that understands the industry and has the experience to review and confirm your product’s readiness for market – efficiently, reliably and promptly.