Our Services
Regulatory Strategy and Compliance
Talent. Strategy. Results.
How Can We Help
Conduct gap analyses to determine compliance with IMDR/EUMDR requirements. Identify the classification of medical devices and applicable conformity assessment routes. Provide guidance on creating and maintaining Technical Documentation. Ensure the Technical File or Design Dossier meets EUMDR Annex II and Annex III requirements. Ensure the product complies with ISO 14971 for risk management. Assist in preparing clinical evaluation reports (CERs) under EUMDR Annex XIV. Guide on Post-Market Clinical Follow-Up (PMCF) planning and reporting.
How We Work
A Process Proven Time & Time Again
Key Benefits
- Operational efficiency improvement and cost savings.
- Product or service quality enhancement.
- Greater customer satisfaction and loyalty.
- Compliance with industry standards and regulatory requirements.
- Increased competitiveness in the market.
Address:
Flat T-102, DNA Opulence Apartment, Whitefield, Bangalore – 560066
Phone:
+91 9731308809
Email:
vinu@expertconsultants.com
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Services
Quality Management System (QMS) Implementation
Quality Auditing
Certification Support
Regulatory Strategy and Compliance
Supplier Quality Management
Services
Training and Capacity Building
Process Improvement
Risk Management
Data Analysis and Reporting
Project-Specific Quality Support
Customer Satisfaction and Feedback