Clinical Evaluation

  • Audit Report And Compliance
    Audit Report And Compliance
    Operon Strategist helps manufacturers design a PMS plan specific to a product or family of products.
  • Handling Customer Compliants
    Handling Customer Compliants
    Medical device manufacturers’ ultimate user is the customer whose satisfaction in using a particular product is of utmost importance.
  • Audit Report And Compliance
    Audit Report And Compliance
    We 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.
CAPA compliance.
Audit Report & Compliance.
Labeling 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.

Related Projects:

Handling Customer Complanits

Name: Handling Customer Complaint
Year: 2001
Type: Got it

Audit Report NAd Compliance

Name: Audit Report & Compliance
Year: 2003
Type: Got it

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