We support more than 250 customers worldwide in regulatory issues in connection with medical devices.
We will find dependable, individual and useful solutions for your request.
Do you have any questions? Please get in touch with us...
GMP, QM & Regulatory Affairs Consulting
Our core competence lies on medical engineering
Our core competence lies on medical engineering.
Since 1994 we support manufacturers and distributors of medical devices to fulfill regulatory requirements established with European Medical Device Directive 93/42 EEC on June 14, 1993. We conduct regular FDA mock audits, prepare companies for FDA inspections, attend inspections as moderator and coordinate subsequent measures with the company if desired by our clients.
We offer our clients dependable, serious and practical services, e.g. in order to build up, maintain or complete adapted quality systems for the company. We consider the respective requirements, which the company has to implement due to its activities - among other things:
We assist clients in the compilation of technical dossiers for the admission of medical devices to put them into circulation at European and international markets:
Standard Technical Documentation (STED) for submissions in
STEDs are completed with national requirements of the respective region / country.
Section 417 of the "Food and Drug Modernization Act" of the year 1997 (FDAMA) demands that each company has to be registered with FDA in connection with production, processing, advertisement, fitting or adaptation of medicine or medical devices, which are imported in the United States and they have to indicate
The FDA published the "Final Regulation" on November 27, 2001 that implemented the requirements (Federal Register, Vol. 66).
The date of commencement of this determination was on February 11, 2002.
Each company has to inform the FDA about the name, address and telephone number of their United States Agent for their medical devices. The determination (21 CFR 807.40) indicates, that each foreign company is allowed to name only one United States Agent, who either is located in the USA or the place of business resides in the USA. The foreign company can appoint its United States Agent as "Official Correspondent", but it isn't a must.
Since 2014 we have an own company in Brazil and we operate as an "Brazil License Holder" there.
Admission procedure in Brazil in general:
European representativeFor producer of medical devices with registered office outside of Europe
We offer a service of European Authorized Representative for manufacturer of medical devices with registered office outside of Europe.
Hereby we take care of companies during the admission and registration of their medical devices and keep in touch with the appropriate authorities and notified bodies. If you are interested in this service, we will generate an adapted offer for your company and your products.
Germany · USA · BrazilProvision of logistical services
Our primary focus lies on the consultation for issues of GMP and Regulatory Affairs requirements. Due to our international direction we have our own companies in the USA and Brazil, beside the main location in Germany. Therefore we are able to offer logistical services in the respective regions. Hereby we open the possibility for our clients to have their own store in respective countries and to provide products quickly and uncomplicated to clients. Reshipments can be collected and consolidated beside storage and distribution.
Clients can optimize their international appearance by using MEDAGENT as well-known and reliable service provider as contractual partner.