Regulatory and Quality Solutions
Expert Regulatory & Quality Solutions for Medical Devices
Our end-to-end support includes the development, implementation, and continuous improvement of robust Quality Management Systems (QMS) tailored to your business model and product class, whether you are developing an LDT (Laboratory Developed Test) or an IVD test. We ensure alignment with global regulatory requirements like FDA 21 CFR Part 820, ISO 13485, and EU IVDR, helping you navigate complex compliance landscapes with confidence. From gap assessments and internal audits to document control, training programs, and regulatory submissions, our comprehensive QMS and compliance services support sustainable growth, operational excellence, and readiness for inspections and audits.
Our expertise includes:
Regulatory & Quality Compliance:
Our regulatory experts will work closely with your team to interpret evolving requirements and implement fit-for-purpose compliance strategies tailored to your product type, market entry goals, and risk profile.
We support the preparation of technical documentation, design history files (DHF), risk management files, and regulatory dossiers that align with the expectations of regulatory bodies such as the FDA, EMA, Notified Bodies, and global health authorities. Whether you're pursuing a 510(k), De Novo, PMA, CE Mark under IVDR, or operating as a manufacturer of LDTs, we help ensure your processes, documentation, and quality systems are inspection-ready and audit-resilient.
Our goal is to minimize regulatory delays, reduce compliance risk, and create a solid foundation for long-term market success.
QMS Development & Implementation:
We are your partner in designing, building, and implementing customized Quality Management Systems (QMS) that meet the rigorous requirements of ISO 13485, FDA 21 CFR Part 820, and other global regulatory frameworks. Our approach is scalable and flexible and is tailored to the unique needs of startups, established manufacturers, CLIA laboratories. We will work with you for development of your Laboratory Developed Tests (LDTs) and your in vitro diagnostic (IVDs) products.
Our comprehensive QMS solutions include the creation of policies, standard operating procedures (SOPs), work instructions, and templates that support end-to-end quality assurance, including design control, risk management (ISO 14971), document control, supplier qualification, CAPA, complaint handling, and internal audits. We also provide hands-on support for implementation, training, and readiness for regulatory inspections. Whether you're establishing a QMS for the first time or upgrading an existing system to meet new market demands like or transitioning to the FDA QMSR (Quality Management Systems Regulation), we will ensure your system is robust, compliant, and aligned with your product development and commercialization timelines.
Risk Assessment (ISO 14971):
We provide comprehensive risk management services aligned with ISO 14971, the international standard for the application of risk management to medical devices, including in vitro diagnostic (IVD) and Laboratory Developed Tests (LDTs). Our approach ensures that risk is proactively assessed and controlled throughout the entire product lifecycle—from concept, design, and development to manufacturing, distribution, and post-market surveillance.
Our team supports you in developing a complete Risk Management File (RMF), including:
- Risk Management Plan (RMP)
- Hazard Identification and Risk Analysis
- Risk Evaluation
- Risk Control Measures
- Residual Risk Evaluation
- Benefit-Risk Analysis
- Post-Market Risk Management
This process will support your regulatory submissions (e.g., 510(k), PMA, De Novo, CE Mark under IVDR), strengthen your Quality Management System (QMS), and enhance your preparedness for inspections and audits by FDA, Notified Bodies, or other authorities.
Investigations & Troubleshooting:
We provide end-to-end support for managing quality issues and ensuring regulatory compliance through structured investigations, root cause analysis, and resolution of nonconformities. Our approach is grounded in industry best practices and regulatory expectations from bodies such as the FDA (21 CFR Part 820), ISO 13485, and EU MDR.
Our services include:
- Complaint Handling
- Nonconformance Investigations
- Root Cause Analysis (RCA)
- Corrective and Preventive Actions (CAPA)
- Recall Management
- Trend Analysis and Continuous Improvement
These services will not only help resolve immediate quality issues but also build a stronger, more resilient quality system that supports compliance and long-term product success.