Providing documentation to support all stages of your Product Development Life Cycle – from concept to commercialization – is essential to your product development process. For medical devices, ensuring that your medical device is manufactured under design control is a quality system requirement.
Our experienced staff can help you build and implement a Product Development Life Cycle or Design Control program to provide infrastructure for your product development through product commercialization, as well as provide a framework for an expeditious review of the entire process by your management team.
Our life cycle and design control documentation experience includes:
- Working with your product development, manufacturing, product/technical support, regulatory, and quality teams to define a product development life-cycle suitable for your organization.
- Developing checklists and forms to ensure comprehensive, expeditious design reviews at the critical stages of the development life-cycle.
- Developing a structure to allow for concise management review meetings and to address continuous improvement opportunities.
If you would like more information, get in contact with us directly here.