Medical Device Services
Strategic planning for product development- Classification of medical devices and legal borderline determination (especially between medicinal products and medical devices)
- Identification of the Directive(s) and harmonized standards applicable to the product
- Definition of the product-specific requirements
- Conformity assessment procedure and risk analysis
- Pre-clinical and clinical evaluation including clarification on the needs
- Preparing and arranging advice meetings with Notified Body
Support to the implementation, conduct and evaluation of clinical studies according to the relevant guidelines:
- Clinical investigation plan and final study report according to ISO/DIN 14155 and ICH/GCP
- Study site selection
- Investigator trainings as needed (device-specific, study procedures according to GCP, vigilance training)
- Support in selecting and contracting a CRO
- CRO management
- Clinical trial applications and ethics committee applications
- Other medical writing needs, i.e. draft publication
Writing of or support to the technical documentation
- Classification
- Declaration of conformity
- Risk analysis and risk management
- List of standards used to satisfy essential requirements
- Product description
- Product specification
- Pre-clinical evaluation / biocompatibility
- Clinical evaluation
- Label / instructions for use
Function of the Authorized Representative for non-EU manufacturers
- Distribution and labeling oversight
- Communications with authorities
- Customer requests as needed
