The MDKT manages your MDD-MDR transition process!
Services
Are you up for the MDD-MDR transition?
We can help you addressing identified gaps in your technical documentation and data management of clinical performance and safety. We assist you in preparing for technical testing to meet current standards, and plan with you how to demonstrate preclinical and clinical performance and safety. We analyse your current situation for clinical performance and safety claims and match them with available literature and data. In case of missing clinical data, we analyse an appropriate path to generate relevant clinical data.
Our preclinical services include:
User Requirements
Requirement specifications
Design Verification & Validation
Software development and validation
Biocompatibility assessments ISO 10993 incl. Lab Testing
Electronic and Electric testing and particular standards
Usability
Risk Management File according ISO 14971
Cleaning, Desinfection and Sterilisation ISO17664
Labelling and Instructions For Use (IFU) and marketing claims
Our clinical services include:
Clinical Evaluation Plans
Clinical Evaluation Reports
Design Verification & Validation
Interface Post-market Surveillance and Risk Management
Clinical Investigations
- Post market Clinical Follow-up (PMCF)
- PMCF-Studies
Clinical Trial Management
- Multi sites/ Multi-Country Management
- Data Management
- Key Documentation
- Data Capture, Monitoring, and Data clarification
- Statistics
- Reporting and Medical Writing
Our Post-Market services include:
Pricing and Reimbursement
Post-market Surveillance plans and reports
Complaint management and event reporting (Vigilance processes)
Product lifecycles
Phase out planning