Medical Device Safety (MDS) Consulting Services

Thorough investigation into adverse events linked to device usage.
Determination of device's role in patient outcomes.
Evidence-backed reporting for clarity and transparency.
Support in responding to health authority queries on adverse event investigations.

Proactive identification of potential safety issues.
Data-driven methodologies for early warning signals.
Trend analysis to anticipate future challenges.
Expert guidance in communicating signal findings to regulatory bodies.

Detailed examination of safety data to detect patterns.
Interpretation of safety metrics for actionable insights.
Quantitative and qualitative reviews for a complete safety profile.
Assistance in framing safety data analyses for regulatory submissions.

Compilation of safety data for regulatory submissions.
Periodic safety update reports (PSUR) and Clinical Evaluation Reports (CER).
Integrated data views for comprehensive safety profiling.
Expert review and editing to ensure clear communication to health authorities.

Comprehensive reviews of existing scientific literature.
Correlation of published data with product performance.
Evidence-based insights for informed decision-making.
Assistance in presenting literature-based findings to health authorities.

Continuous monitoring of medical devices once in the market.
Identification of potential safety concerns or trends.
Regulatory compliance assurance and real-time updates.
Assistance in responding to health authority inquiries related to post-market data.

Ongoing evaluation of device's long-term performance and safety.
Feedback loops to manufacturers for quality improvements.
Planning and reviewing strategies for long-term clinical data collection.

Customized training sessions on device safety regulations and best practices.
Empowerment of teams to understand and implement safety standards.
Updates on the latest guidelines and industry changes.
Training to effectively communicate with health authorities.

Expertise in drafting, refining, and finalizing documentation for regulatory bodies.
Assistance in creating robust plans for safety assessments and follow-ups.
Review and edit submissions to ensure clarity, precision, and compliance.
Strategic support in responding to queries and feedback from health authorities.

- The MDSS team brings extensive experience in pharmacovigilance, including with combination devices which present unique safety monitoring challenges.
- This includes adverse event analysis as well as signal detection and risk management.
- Our strategic efforts help maximize the safe use of novel technologies and move products efficiently through development and commercialization.