CSI offers...

• International Regulatory Strategy for compliance with Medical Devices Directives, CFR 21, and many other global regulatory requirements.

• Quality Systems development to meet European, US and International standards ( ISO 14155 and FDA Quality System Regulation).

• Project management and technical services for new product development and design transfer to manufacture.

• Design and management of Clinical Trials, Investigations, User Evaluations and Post-Market Surveillance, Post Market  Follow-up Studies and Post Market Surveys.

• Technical and scientific writing to support regulatory submissions and technical files.

• Business Development Services and medical device brokerage and facilitation services to aid the clinical inventor bringing innovative technology and devices into the market.

• Market research, identification of business partners, preparation and review of business and marketing plans.

• Graphic Design and Medical Art Work to support Patent Applications, Instructions for Use, and Operator Guides and Manuals.

CSI can help bring your product to market, your innovative ideas to reality and ensure compliance with global regulatory requirements. Follow the links to learn more of what we offer, or contact us today to discuss your needs.