Product category: Certification and testing of medical devices, quality assurance
safety testing | qualification | validation
In cooperation with international strategic testing houses we provide risk-based solutions for product safety testing and evaluation such as biocompatibility assessment according to ISO 10993-1 ff, extractables and leachables testing according to ISO 10993-18 and toxicological evaluation of medical devices and container closure systems for drug products. In addition we provide solutions for equipment qualification and process validation with specific expertise in sterilization technologies.
/ product and production risk management / biocompatibility and toxicological testing and evaluation / preparation of validation master plans / equipment qualification / process validation / sterilization validation
Our trainings (also in-house training) are customized to the specific and individual needs of the customers. We provide international training on European and US FDA regulatory aspects including:
/ CE marking of medical devices / preparation of technical files / risk management according to ISO 14971 / preparation of clinical evaluation / post-market surveillance strategies / vigilance requirements / CAPA system handling / vigilance master plan / biocompatibility evaluation / toxicological evaluation of extractables/leachables / quality management systems
MT Promedt Consulting GmbH is a Germany based regulatory consultancy operating in the international healthcare market (medical device, in vitro diagnostics, pharmaceutical and biotechnology industry). Founded in 1995, the company operates two German offices in St. Ingbert/Saarland and Tornesch/Schleswig-Holstein and a US office in Salt Lake City/Utah.
philosophy The objective of our company is to provide excellent and hands-on assistance for our clients. Considering the sponsor's perspectives we tailor our competent services to meet the customer's needs in a cost-effective manner and within a clear timeline. We understand and enjoy the entrepreneurial spirit inherent in the small and medium sized companies. Benefitting from years of experience in the fields of production, quality assurance and regulatory affairs, MT Promedt Consulting offers full service packages in order to speed up the process from product development to market clearance. Our commitment is to help our clients to obtain a remarkable advantage in these markets.