Introduction
Prosystem USA LLC is an international consulting firm for the healthcare industry located in San Diego, CA and Hamburg, Germany.
Our services are:
Risk Management Consulting covering the practical implementation of the new requirements (ISO 14971:2000) throughout an overall Risk Management Process (new: Risk Management Policy, Risk Control, Training, ...).
Medical Software: Risk management for medical software. Validation and verification activities.
Project Management - starting from training via consulting up to realization of complete projects:
Optimization and Validation of your processes according to the requirements of the Medical Device Directives (CE-marking) in Europe and/or the FDA (USA); e.g. practical implementation of Harmonized Standards like EN 60601-1-4.
Inhouse Training and Consulting to subjects of Medical Devices Regulations; e.g. update of European legislation, Risk Management, software validation and verification, Medical Device Consultants, Safety Officer, Technical Documentation, Instructions for Use (IFU).
International Standards and Trend Consulting for Medical Devices Manufacturers: What are the upcoming standards and technologies?
Quality Management: Application of ISO 13485:2003 for Medical Devices Manufacturers; Implementation, e.g. of document management systems and standard operating procedures for the development of medical hardware and software.
Our services are:
Risk Management Consulting covering the practical implementation of the new requirements (ISO 14971:2000) throughout an overall Risk Management Process (new: Risk Management Policy, Risk Control, Training, ...).
Medical Software: Risk management for medical software. Validation and verification activities.
Project Management - starting from training via consulting up to realization of complete projects:
Optimization and Validation of your processes according to the requirements of the Medical Device Directives (CE-marking) in Europe and/or the FDA (USA); e.g. practical implementation of Harmonized Standards like EN 60601-1-4.
Inhouse Training and Consulting to subjects of Medical Devices Regulations; e.g. update of European legislation, Risk Management, software validation and verification, Medical Device Consultants, Safety Officer, Technical Documentation, Instructions for Use (IFU).
International Standards and Trend Consulting for Medical Devices Manufacturers: What are the upcoming standards and technologies?
Quality Management: Application of ISO 13485:2003 for Medical Devices Manufacturers; Implementation, e.g. of document management systems and standard operating procedures for the development of medical hardware and software.
For further information please contact:
Mrs. Sima Niknafs
Phone 619-595-4875
Fax 619-595-3150
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
Mrs. Sima Niknafs
Phone 619-595-4875
Fax 619-595-3150
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
