Approval of medical devices
Qualification and classification
The qualification and classification of a medical device are based on its intended purpose and risk potential. Topics are:
- Formulation of intended purpose
- Qualification as medical device/ accessory/ non-medical device
- Identification of safety characteristics
- Risk classification of the product and its components
Applicable
Regulations
Standards, guidelines and directives are legally binding for medical devices. We support you with:
- Identification of applicable regulations
- Implementation
- Regional specifics
- Harmonization of regulations
- Traceability
- Reduction of the documentation effort
Development of an approval strategy
The right approval strategy determines how quickly and safely you receive market approval.
- Decision-making basis for regional markets
- Identification of equivalent products
- Positioning of your product
- Design roadmap
- Time horizons
- Documentation optimization
Requirements Management
Clear requirements management is the essential basis for effective product development and the validation of your medical device.
We support you with:
- Market requirements
- System and product requirements
- Regulatory requirements
- Traceability
- Structuring and formulation
- Validation of requirements
- Training on methodology and formulation of requirements
Clinical evaluation
A clinical assessment must be carried out according to MDR for medical devices of all risk classes.
The aim is to demonstrate the safety, effectiveness and performance of clinical use.
Our support:
- Specify the clinical data
- Relevance in terms of impacts
- State of the art
- Hazard analysisLiterature search
- Clinical investigation plan
- Evaluation of the results
- Clinical assessment report
- Planning and implementation of the updates
Post Market Surveillance
They must ensure the safety and effectiveness of their products once they are placed on the market.
To do this, information must be proactively collected, evaluated and, if necessary, corrective measures taken. Almost all processes have to be included.
We support you with:
- Identifying the required information
- Organizing the collection of information
- Systematic collection, evaluation and evaluation of dataImplementation of corrective and improvement measures
- Meeting the documentation requirements for monitoring plans and reports.