Our focus is on reliable, individual and practice-oriented solutions. They are realized by our full-fledged staff - for each topic the person with the required qualification.
Internal and external trainings related to the topics Quality Management, GMP requirements and Regulatory Affairs, ensure adequate and up to date qualification of our staff. To recess knowledge and develop experience, staff members participate on audits as well as preparation, moderation and attendance on inspections for the US American FDA, Brazilian ANVISA or other national or international Competent Authorities.
MEDAGENT GmbH was established in 2000 by Nicole and Franz Menean. By establishing MEDAGENT, Inc. in Portsmouth, NH, USA in 2004 and MEDAGENT do Brazil Ltda. in the region of Sao Paulo in 2014, MEDAGENT expanded internationally. Meanwhile 250 customers worldwide are supported - all of them are in medical devices.
We sell services and not templates!
We are independent and want to keep it.
For us, independence means to cooperate with third parties, but there are no "sting operations" between us and our business partners. We recommend solutions for the software, certification companies, notified bodies, experts, laboratories, lawyers, assessors etc. This happens with conviction and not due to commissions. We refuse commissions on principle!
We have full-fledged employees to provide reliable, individual and practice-oriented solutions - for each request the person with the required qualification.
We work together with reliable business partner to be able to offer reliable solutions for our clients.
We support our clients indirectly, too, by yielding our knowledge and engagement in expert committees and stakeholders.
We support more than 250 clients worldwide for the issues Quality Management and Regulatory Affairs. Our clients are small- and medium-sized companies from 2 till 2000 employees. Most of them are from Germany, Austria, Switzerland and the USA.
We support more than 250 customers worldwide for the issues Quality Management and Regulatory Affairs. Our customers are small- and medium-sized companies from 2 till 2000 employees. Most of them are from Germany, Austria, Switzerland and the USA.