Collection and evaluation of data, from the process design stage through commercial production, by providing scientific evidence that a process is capable of consistently delivering a quality product in compliance with requirements.
Development of validation strategies
Documented plan for each of the stages required to bring a medical device from design to market following applicable standards and regulations.
Process & Product Characterization
Perform the collection and evaluation of data throughout the medical device validation stages from conception to production, including the Risk-based identification of critical process parameters to provide the documented compliance evidence that a process is capable of consistently delivering a quality product.
Product, Process & Equipment Validation (IQ, OQ, PQ)
Creation of documented protocols to perform the installation, operational, and performance qualification of medical devices to demonstrate compliance to requirements.
Computer Software Validation
Development and execution of documented protocols to validate software following standards and regulations for compliance with requirements.
To develop and execute protocols to perform the installation, operational, and performance qualification of medical devices packaging to customers' applicable standards.
Test Method (TMV)
Development of documented protocols and execution of the validation for a particular test procedure to ensure it is suitable for its intended purpose.
New Supplier Integrations
Supplier Quality Engineers (SQEs) support and manage the supply chain process by evaluating and approving suppliers to ensure compliance with regulatory standards and component product requirements.
Calculate and validate the sterilization configuration loads for medical devices to destroy all microorganisms and their pathogenic products by any of the various methods applied to comply with the customer's sterility assurance level.