Process & Test Method Validations
We are a group of engineers, scientists, and managers with extensive years of experience in the medical device industry. We are fully engaged with the customers’ needs to meet the regulations and improve their processes. Process and Test Method Validation are always in the scope of FDA and ISO 13485 to make sure the products meet the requirements consistently; for that reason, we offer the following services:
- Assess current Process and Test Method Validation policies to identify gaps according to FDA and ISO 13485
- Establish Process and Test Method Validation policies according to FDA and ISO 13485
- Establish sampling plans for Process and Test Method Validation
- Training in all relevant topics of Process and Test Method Validation
- Remediation of Process and Test Method Validation
- Determine process risk for each validation
- Establish PV Metrics and Validation Review Board (VRB)
