Our regulatory and quality consultancy services help navigate the complex landscape of medical device regulations. We offer strategic advice, comprehensive documentation support, and ensure adherence to quality management systems.
Having guidance for regulations of medical and in vitro diagnostic devices in any stage - from concept to commercialization - from a CRO is a great privilege.
With our sister company AdviQual, we provide high caliber consultancy for Medical Device Regulation (EU) 2017/745 (MDR), In Vitro Diagnostics Medical Devices Regulation (EU) 2017/746 (IVDR) & FDA submissions.
You may easily increase your team's competencies and efficacy with our experience that is derived from more than 60 device groups that we have served.
Here is the list of consultancy services, we offer for obtaining CE certificate or FDA approval and comply with MDR or IVDR:
- Quality Management System Establishment as per EN ISO 13485:2016
- Improvement of the Current Quality Management System
- Quality Management System Audit
- Design Process Management
- Design Control Consultancy
- Technical File Preparation - MDR 2017/745, IVDR 2017/746
- Technical File Review
- Risk Analysis Report Preparation as per EN ISO 14971:2019
- Post Market Surveillance (PMS) Plan / Report Preparation
- Periodic Safety Update Report (PSUR) preparation
- Biocompatibility Assessment Plan / Report Preparation
- Toxicological Risk Assesment
- Usability Protocol & Report
- Mock/GAP/Supplier Audit
- Clinical Trial Services
- Documentation (Protocol, Case Report Form, Investigation Brochure, Inform Consent Form, Master File etc)
- Submission to Ethical committee & MoH
- Clinical investigation Management
- Clinical trial Monitoring / Audit
- Clinical Trial Final Report preparation
- Process Validation Protocol & Report
- Sterilization Validation
- Injection / Extrusion Validation
- Packaging validation
- Cleaning validation
- Assembly validation
- Transport validation
- Transport Simulation Tests (ASTM Standard)
- Package Integrity Tests
- Accelerated Aging Tests
For more detailed service information, please contact with us info@desiaclinical.com
