Medical products
Consulting in the field of medical device regulation
We are happy to support you with the technical parts of your technical documentation in accordance with the Medical Devices Regulation (EU) 2017/745. We prepare biocompatibility assessments based on the relevant data, in particular the ISO 10993 and ISO 18562 series. We coordinate the development of the underlying data in partner institutes for you. We develop clinical evaluations according to ISO 14155 in our competence area "infection prevention" e.g. for instrument disinfectants and "wound care" e.g. for wound dressings and wound irrigation solutions. In addition, we support you in the risk assessment according to ISO 14791 of your products, especially with regard to hygienic-microbiological and biocompatibility issues. If the definition of a reprocessing instruction according to ISO 17664 is pending, we support you in the preparation of this documentation.
Infection prevention and wound treatment products
We are also experts in the efficacy evaluation of infection prevention and wound treatment products classified as medical devices, e.g. wound dressings, wound irrigation solutions, instrument cleaning agents as well as instrument disinfectants and instrument reprocessing devices. For medicinal products for infection prevention, e.g. skin, wound and mucous membrane antiseptics, we are happy to advise you on the development of efficacy data in vitro and in vivo.
Dear customers, dear partners,
our family business is happy to be there for you. We pick you up where you are, always fair and with high quality. We want long-term and successful relationships, where we learn and grow from each other. Services are constantly adapted to your needs. We look forward to hearing from you.
Best regards,
