You will find in us an expert partner in all matters related to quality management and quality assurance, as well as certification and approval of your products. Furthermore, together with our cooperation partners, we have created an exclusive competence network, which provides you with comprehensive support in core issues such as liquidity assurance, optimal use of funding, competence build-up for market access and optimal market development.
Exclusively for our clients and together with our team of doctorate-holding specialists, we offer you the consultancy services of actively practicing medical doctors with their knowledge in the fields of medicine, medical technology and medical informatics.
Your individual company situation is in our focus. Become successful with us on your side!
“SOP´s for design and development of class IIa medical devices and class B software, auditing of documents, including, technical documentation for CE-Registration, Gap analysis”
“Appointment of a QMR - quality management representative – (ISO 13485 and US 21 CFR 820), validation of manufacturing processes, risk management (ISO 14971), support during FDA recertification audits”
“Clinical evaluation for soft-tissue implants, market analysis and market monitoring of several product groups used during biopsies”
“Validation of specific vaccines, laboratory accreditation/GLP certification (ISO 17025)”
“Quality management system for Legal Representative Services, focus on clinical studies with pharmaceuticals”