Our
Services
Consulting Projects and GAP Assessment Services
click through each tab to learn more
Collect Real-World Data Using Big Data Databases Worldwide
Strategic Market Entry Into The European Union
Founders / Entrepreneurs
Expert in Business Development and B2B initiatives
Collect Real-World Data Using Big Data Databases Worldwide
Medical Device Regulation (MDR) Gap Assessments and Remediation
- Clinical Sections of the Quality Management System
- Clinical Evaluation Assessment of Processes and Identification of What Could Trigger an Update
- PMS Plans/PMCF Plans and Reports Implement Requirements Under EU MDR: inputs, outputs, and triggers
- Summary of Safety and Clinical Performance (SSCP) Training, Development, and Ensuring the Correct Reading Level
- PMS Report (Class I devices) and PSUR (Class II and III devices) Training and Development
- Benefit-to-Risk Determinations Using Established, Proven Methods
- Identifying and Avoiding “Significant Change” Requests that Would Require Manufacturers to Submit an MDR Application
- Identify documents that need to have internal consistencies involving clinical data?
- Building and Leading High Performing Teams
Implement Six Risk-Based Approaches to Proactively Collect Sufficient Clinical Evidence and Data
- Surveys
- Hospital Databases
- Investigator-Sponsored Studies
- Country-Specific Registries
- Small Single-Arm Clinical Trials
- Large Randomized Clinical Trials or Single-Arm Clinical Trials
Meta-Analysis of Literature or Hospital Systems Clinical Data
our
Clinical, Regulatory & Quality Services
- Classification and reclassification of devices as per EU MDR
- Impact Analysis and Gap Assessment
- General Safety and Performance Requirements (Annex I) Compliance check
- Prepare or Update List of Applied Standards (LoAS)
- Prepare or Update Technical Documentation
- Labelling
- IFU preparation and updates
- Guidance on UDI implementation
- Guidance on PMS and PMCF Plans
- Preparation of Training materials
- Provide Trainings