PROSYSTEM USA LLC is an international consultant company for the health care industry and offers extensive services in quality and project management for the medical device industry.
The company was founded by Prof. Dr. Juergen Stettin and his partner Oliver P. Christ in 1999. It is located in San Diego, CA/USA, and serves customers in over 20 countries worldwide.
Our customers are mainly producers and engineers of medical devices, managers of regulatory affairs and risk, agents of quality management, pharmaceutical industry, universities as well as notified bodies.
As an active member of different groups of engineering standards we are able to provide you with detailed information regarding emergence and implementation of essential standards.
Do you need assistance for the (pre)market approval of your medical devices? Your company wants to approach new markets?
PROSYSTEM AG will assist you to answer these and more questions and will help to find the easiest way for getting your medical devices market approval. We will help with all regulatory affairs questions in order to place your medical device into the correct category (also in the borderline sector), to place the product on the market in a timely manner and to maintain a valid state.
Together with our subsidiaries: PROSYSTEM USA LLC. and PROSYSTEM do Brasil Ltda. we are able to offer an extensive portfolio of on-site services to you. Benefit from our long years of experience in regulatory affairs and our knowledge on specific national approval processes for example if you want to approach the Asian or Canadian market.
Our specialists from PROSYSTEM AG support you with our long-standing and manifold experience in the field of in-vitro diagnostics. We accompany you all the way from the idea of a product, the challenges of international product registrations to the downstream processes of already marketed products.
The aim of PROSYSTEM AG is to provide an extensive support to fulfill the complex requirements towards laboratories, healthcare facilities and manufacturer of in-vitro diagnostics in order to identify preconditions of a product registration to ensure marketing authorizations for the desired markets in a timely manner.
PROSYSTEM AG assists you within our services in:
The classification of your medical device according to Annex II of the directive 98/79/EEC; the identification of applicable standards and needed technical documentation; performance evaluation; assessment of already created documentation; accompaniment in market registration, market entry and post production phases.
The clinical evaluation is required for each medical device regardless of its classification. Thereby, the MEDDEV 2.7.1 guideline is a helpful orientation with regard to the methodological approach as well as the documentation of the content. The clinical evaluation is a continuous process and needs to be kept up-to-date over the entire product life cycle. The requirements of the MEDDEV 2.7/1 Revision 4 increased significantly. According to the amendments, the clinical evaluation should no longer focus only on the safety and performance of medical devices; it should also take the benefit and usability for patients, user and third parties into consideration. In addition, the assessment of alternative treatment options is of greater importance in the fourth Revision. Moreover, the evaluation criteria for the analysis of scientific literature were substantially expanded.
Join us at Medica for more information!