Audit Report And ComplianceOperon Strategist helps manufacturers design a PMS plan specific to a product or family of products.
Handling Customer CompliantsMedical device manufacturers’ ultimate user is the customer whose satisfaction in using a particular product is of utmost importance.
Audit Report And ComplianceWe Provide Medical Device Post Market Support For CAPA compliance , Audit Report & Compliance , Labeling Compliance.
Clinical evaluation is the assessment & analysis of clinical data pertaining to a medical device to verify its clinical safety & performance.Operon Strategist helps clients prepare a comprehensive clinical evaluation report by identifying the general safety & performance requirements that require support form relevant clinical data.We comb through various scientific databases such as PubMed , Cochrane etc. to search for available clinical data relevant to the device & its intended use.
Handling customer complaints:
Medical device manufacturers ultimate user is the customer whose satisfaction in using a particular product is of utmost importance.Hence an efficient method of receiving & documenting customer complaints must be implemented. Moreover, detailed investigation must be carried out to determine the reason for the customer complaint & accordingly suitable corrective &/or preventive action must be implemented.
We Provide Medical Device Post Market Support includes Following stages:
Ongoing system and maintain the compliances during ongoing commercial manufacturing process.
Audit Report & Compliance.
Clinical Evaluation & Post Marketing Survillance.
Medical Device Reporting.
Customer Complaints.We can handle such incidences very effectively and efficiently.
Design Output, Design verification & Design Validation.
Medical device vigilance & medical device reporting are two of most commonly used methods for reporting adverse events in the EU & US respectively. Other sources for gathering information includes product or customer surveys, literature review, service reports, regulatory filings, etc.