Why Choose Us
Accelerating Medical Device and IVD Market Access Worldwide
End-to-End Support
From concept to market launch and beyond.
Global Expertise
Serving India, Europe and USA with deep regulatory knowledge
Specialized Team
Experts in QMS, Technical Documentation, Quality Assurance, Regulatory Compliance, RMF, D&D and Clinical for medical devices and IVDs
Tailored Solutions
Customized services to meet your unique business and regulatory needs.
Our Services
A Unified Platform for QMS, Regulatory and Clinical Excellence
- 1
QMS Documentation And Implementation
Effective Documentation and Implementation of Quality Management Systems (QMS) in line with global standards such as…
- 2
Medical Device Product Registration Services
We assist in preparing and submitting regulatory applications for global markets, including US FDA QSR Part 820…
- 3
Regulatory Compliance
Comprehensive regulatory support for CDSCO license, CE marking, US FDA QSR Part 820 submissions, MDSAP and global…
- 4
INDIA -CDSCO license
Medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices…
- 5
QA/RA Advisory Service
Expert guidance on Quality Assurance (QA) and Regulatory Affairs (RA) to streamline compliance and market approvals.
- 6
Training Service
Tailored training programs to equip teams with the latest knowledge in regulatory, quality, and clinical requirements.
- 7
QMS Audit Service
Comprehensive audits to assess and strengthen your Quality Management Systems (QMS) in line with global standards such…
- 8
Clinical Investigation
Complete documentation of clinical investigations, ensuring compliance with GCP and regulatory expectations.
- 9
Clinical Evaluation
Preparation and review of CERs to demonstrate clinical safety and performance of medical devices as per MDR/IVDR.
- 10
Post Market Clinical Follow Up (PMCF)
Systematic PMCF studies and documentation to continuously ensure device safety and effectiveness in real-world use.
- 11
Periodical Safety Update Report (PMS & PSUR)
Accurate PSUR preparation and maintenance to meet ongoing safety reporting obligations.
- 12
Summary of Safety and Clinical Performance (SSCP)
Clear, compliant SSCP documents for transparency with regulators, healthcare professionals, and patients.
- 13
Biostatistics and Medical Writing
Statistical analysis and expert medical writing services to support clinical, regulatory, and scientific submissions.
- 14
Design Validation
Verification and validation services to ensure that devices meet intended use and regulatory requirements.
AI and Cybersecurity in Healthcare
Assessment and integration of cyber security measures to protect medical devices and healthcare data.
.webp)