What to Know
A lead validation engineer takes responsibility for approving the full manufacturing process. Validation engineering expertise ensures that consistently high-quality product will result. Specifications and steps are verified to show that your medical device meets regulatory standards for safety and effectiveness.
Validation engineers oversee and direct the manufacturing process, systems and equipment that will produce your medical device. The validation process ensures precise production equipment calibrations, settings and durations are met.
How We Can Help
Every medical device project requires the expertise of a validation engineer. You can request certain experts, or ask for recommendations from us. We work with you to find the best approach for your project, at the best value. Our services include:
- Validation strategy and coordinated activities for major projects
- Project management of a validation engineering initiative (in-house or ours)
- Leading cross-functional SMEs in validation activities and change management
- Create, review, approve documentation across disciplines for regulatory submission or response
- Direct and oversee all outsourced validation assignments