Medical Devices Services – possible scope

#1

• Verification and evaluation of the Product’s technical documentation
• Regulatory support and regulatory intelligence
• Contact with local Authorities
• Handling of variations: instructions of use, labels, CE certificates update, design changes, etc.
• Pharmacovigilance

#2

• Deep market research
• Feasibility study
• Regulatory strategy
• Finding partners
• Support during business negotiations
• Project lead

#3

• Assessment against the definition of a medical device
• Defining the purpose of the Product
• Classification of the Product
• Clinical assessment
• Technical documentation verification
• Preparation of the Declaration of Conformity
• Trade name registration, preparation of packaging, label and instruction design
• Support in the certification procedure, contact with the Notification Body
• Registration support, contact with Regulatory Authoroties