Supporting your product from concept through commercialization and beyond — covering design controls, validation, risk management, and software lifecycle compliance on the front end, and complaint handling, post-market surveillance, and recall management once your product is on the market.
Our specialized services in this area include:
Ensuring that medical device development follows the proper design history file (DHF) requirements.
Leading FMEA sessions and developing Risk Management Files (ISO 14971), including cybersecurity risk management (FDA premarket guidance) for SaMD.
Validating software and automated systems under GAMP 5.
Designing and executing IQ/OQ/PQ protocols for manufacturing equipment.
Ensuring software development processes for Software as a Medical Device meet IEC 62304 classification and documentation requirements.
Developing integrated quality system strategies for products that combine drug, device, and/or biologic constituents.
Guiding the regulatory and technical analysis to establish whether a combination product's primary mode of action is drug, device, or biologic.
Managing the full pipeline from customer complaint intake through investigation, reportability determination, and regulatory submission — including MDRs for the US and Vigilance/PSURs for international markets (EU MDR/IVDR).
Leading the execution of product removals or corrections, including health hazard evaluations (HHE), strategy development, and coordination with regulatory agencies.
Developing and maintaining proactive surveillance plans and clinical follow-up reports to satisfy EU MDR post-market requirements.
Monitoring complaint, nonconformance, and field data to identify emerging quality or safety signals before they escalate.
Compiling comprehensive safety reports that aggregate adverse event data, trends, and benefit-risk assessments for regulatory submission.
From rigorous design controls and validation to proactive post-market surveillance, ensure your technologies remain safe, effective, and compliant.
Safeguard Your Product Lifecycle