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Ensuring Medical Technology Safety Across the Product Lifecycle
At COD Research, we specialize in MedTech Safety services designed to help medical device manufacturers, healthcare providers, and innovators confidently navigate the complex landscape of device safety, regulatory compliance, and risk management. Our mission is to ensure safer products, stronger compliance, and better patient outcomes, from product inception to post-market monitoring.
Our MedTech Safety Services
End-to-End Clinical Evaluation Support
From planning and literature review to CER writing, Gap analysis, and PMS integration
- Clinical evaluation plan (CEP)
- Clinical evaluation Report (CER)
- Literature search plan & Report
- Systematic analysis
- State-of-the-art (SOTA) analysis
- With Quantitative and Qualitative analysis (PRISMA & Cochrane)
Post-Market Surveillance
- Continuous monitoring of product performance in real-world use.
- Trend detection and early warning systems.
- Regulatory database search plan & Report
- Post-Market Surveillance Plan
- Post-market clinical follow-up (PMCF)
- Complaints/ Vigilance reporting
- Medical Information Management System (Call Centre)
- Aggregate Reports: Periodic Safety Update Report (PSUR)/ Post Market Surveillance Report (PMSR)
- Summary of Safety and Clinical Performance (SSCP)
Risk Management
- Comprehensive risk analysis and mitigation strategies.
- Implementation of ISO 14971-aligned risk management processes.
- Hazard identification, risk control, and benefit-risk evaluation.
- Production and Post-production Risk review
Benefit Risk Assessment Document (BRAD)
- Support in Structured approach for evidence generation
- Incorporating patient and/or User preferences
- Implementing Risk controls/ design change (Device) OR additional risk minimization measures, and studies to evaluate their effectiveness (Drug)
- Initiating post marketing safety studies and/or comparative effectiveness studies.
Human Factor Studies
- Formative & Summative Evaluations>
- Summary HFE/UE Report or Usability Engineering File (UEF)>
- Human Factors Documentation>
- Usability Plan>
- Risk Analysis (URRA)
Quality Management System Development & Implementation
We provide end-to-end Quality System and Compliance Support for organizations involved in medical devices and combination products, helping clients establish, improve, and maintain regulatory-ready systems aligned with global requirements. Our services focus on system development, implementation support, and readiness.
Our QMS services include:
- Development of QMS aligned with ISO 13485, 21 CFR Part 820 (QSR/QMSR), EUMDR 2017/745 and applicable combination product requirements
- Creation of Quality Manual, SOPs, work instructions, and templates
- Process mapping and system structuring
- Gap assessment against applicable regulatory expectations
- QMS implementation support and practical guidance
Process Development & Documentation
We assist organizations in defining, documenting, and implementing robust, compliant processes across the product lifecycle. Process development areas include:
- Design & Development controls
- Risk Management (ISO 14971-aligned)
- Document & Record Control
- Change Management
- CAPA and Nonconformance Management
- Complaint Handling & Post-Market Surveillance
- Combination Product GMP interface (Drug-Device, Biologic-Device)
Type of Products supported for MedTech Safety:
- Devices (Across all class with different Risk categories)
- Drug Device Combination Products
Why Partner with Us
Expertise You Can Trust
Our team comprises seasoned MedTech safety professionals with deep expertise in regulatory compliance, risk management, and product safety. We stay up to date with evolving global regulations to deliver reliable guidance at every stage.
Tailored, Customized Solutions
Every medical device is unique, and so are its risks. We tailor our services to your product type, market needs, and regulatory environment to optimize safety and compliance pathways.
Proactive Risk Management
Rather than merely responding to challenges, we help you anticipate, mitigate, and prevent issues before they arise, protecting both patients and your brand reputation.
Comprehensive Lifecycle Support
From pre-market planning to post-market surveillance and reporting, we support your MedTech safety needs end-to-end.
Who We Serve?
Whether you’re launching a new device or enhancing safety systems for existing products, we’re your trusted partner.
Medical Device Manufacturers
Start-ups & Innovators in MedTech
PMS & RMP Teams
Request for Proposal
Ready to elevate your device safety and compliance strategy? Contact us today to discuss how our MedTech Safety services can help you achieve regulatory excellence and safeguard patients.