Facing compliance challenges? Navigating market entry?
How We Can Help
We offer comprehensive consulting services to support the medical device, diagnostics, and life sciences industries in achieving regulatory compliance and quality excellence. Our services are designed to address the full spectrum of challenges that companies face when developing, launching, and maintaining products in regulated environments.
Strategy
We develop robust, customized strategies that align with industry regulations and streamline compliance for our clients. Our approach ensures regulatory pathways are well-defined, helping clients navigate requirements effectively and bringing safe, reliable products to market faster.
Quality Systems
Our team designs, implements, and optimizes QMS tailored to your organization’s needs. We ensure that systems are compliant with global standards, such as ISO 13485 and FDA 21 CFR Part 820, fostering an environment of continuous improvement and operational efficiency.
Risk Management
With deep expertise in risk assessment and mitigation, we guide companies in establishing comprehensive risk management frameworks. Our solutions integrate best practices that prioritize patient safety and product quality throughout the product lifecycle.
Submissions and Approvals
We provide end-to-end support for regulatory submissions, from initial planning and documentation to successful market approval. Our services cover FDA, CE marking, and other global regulatory submissions, helping clients meet regional and international standards.
Audits and Remediation
Our experienced auditors conduct thorough assessments to identify compliance gaps and quality risks. We assist in remediation efforts, developing corrective actions and preventive strategies that strengthen regulatory standing and product reliability.
Post-Market and Compliance
We support clients in post-market monitoring and reporting requirements, helping maintain compliance. Our services include complaint handling, vigilance reporting, and product recalls, all designed to ensure continued regulatory compliance and product quality.
