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, the detailed investigation must carry out to determine the reason for the customer complaint & accordingly suitable corrective &/or preventive action must implement.

We Provide Medical Device Post Market Support includes Following stages:

Ongoing system and maintain the compliances during the ongoing commercial manufacturing process.
CAPA compliance.
Audit Report & Compliance.
Labelling Compliance.
Clinical Evaluation & Post Marketing Surveillance.
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.

Medical Device Manufacturing Unit Design Consulting Services In USA, Dubai, South Africa, New York, Qatar, Algeria, Libya, Shri lanka, Austrlia, Mauritius, Australia, Brazil, Bangladesh, Comoros, Costa Rica, Canada, Central Asia, Colombia, Egypt, Iceland, India, Indonesia, Nigeria, New Zealand, Oman, Peru, Qatar, Israel, European Union, Europe & Middle East, Hong Kong, Kenya, Korea, Kuwait, Liberia, Malaysia, Mexico, Mauritius, Saudi Arabia, Singapore, South & Central Asia , South Africa ,Southeast Asia & Pacific, Sri Lanka, Switzerland, Russia, Singapore, Turkey, Thailand, Ukraine, United Arab Emirates.

Related Projects:

Handling Customer Complanits

Name: Handling Customer Complaint

Audit Report NAd Compliance

Name: Audit Report & Compliance