Medical Device Documentation Services
Our expert team specializes in crafting comprehensive Device Documents, with a focus on CIPs, CIRs, and CERs. We ensure precision and compliance in every aspect of document preparation to meet regulatory standards.
Services We Offer
Clinical Investigation Report (CIR)
Clinical Trial Protocols (CTPS)
Clinical Investigation Plans (CIPs)
Clinical Evaluation Reports (CERs)
Quality Management System (QMS) documentation
What are the reasons for error in device documents?
- Lack of expertise in document writing
- Limited understanding of device classification
- Non-compliance with regulatory guidelines
- Incomplete data gathering
How can you structure effective device documents for regulatory impact?
By working with us, you receive documents that are comprehensive and accurate. We gather and analyze all relevant data for a thorough investigation.
We present complex information in a well-organized and easy-to-understand format.
We stay updated on CDSCO and international reporting requirements.
We ensure the reports are actionable and results-oriented. We also provide professionally written and formatted reports.
Process for effective device document reporting
Step 1
Understating the requirements of clients
Step 2
Regulatory research
Step 3
Data collection
Step 4
Drafting and documentation
Step 5
Quality assurance
Step 6
Client approval and delivery
