The regulatory experts at D-TARGET have over 20 years of individual know-how in medical device, diagnostics and combination products ; offering you an unparalleled source of strategic and tactical input for all your projects. D-TARGET possesses the scientific background and regulatory expertise necessary in handling all US and European requirements to successfully setup and conduct your clinical studies - getting you through the red tape fast and smooth. Our extensive global network of contacts with Notified Bodies, Competent Authorities and trade associations are your key to important savings in time and money. Development of worldwide regulatory strategy and solutions to practical needs concerning:

Europe

CE mark process

• Conformity assessment
• Notified body selection and ongoing contacts
• Development of risk assessments
• Strategy development
• Pre-clinical strategy development
• Preparation of expert assessment
• Liason with Notified Bodies and Competent Authorities

North America

• Strategy development
• Pre I D E process
• I D E
• 510k
• PMA

Diagnostics

• Classification and strategy
• Data requirements
• Authority contacts

Combination Products

• Classification and strategy
• Data requirements
• Authority contacts



For further information on D-TARGET regulatory services, please contact us.