Embracing quality and creating a mindset around quality best practices is the common thread among the companies we work with that are successful at avoiding regulatory issues and are adept at getting to market quickly. These organizations all use an effective quality management solution (QMS) that allows them to catalog, review and act upon every aspect of the product lifecycle. Specifically, they use a QMS to address and manage these things:
- Reviewing quality procedures through an effective methodology for conformance to established regulatory requirements.
- Quality verification of product development records, including samples, test results, analysis and other data.
- Management review processes that includes quality audits, training requirements, and procedural guidelines.
- Submission processes for communication and submission of information to the FDA when changes to testing and product processes have happened.
- Ability to assess product claims, submission data and other relevant information that is part of the product lifecycle.
- Evaluation of necessary processes and procedures that pertain to identification, documentation, evaluation, segregation and submission to governance bodies.
- Implementation of effective quality control processes that verify and validate all activities in the product development lifecycle.
- Manage documents that can be used for future product development or used for validation during FDA review.
- Create and manage complaint and corrective actions procedures and catalog all pertaining activity.
With a QMS in place, we find that all these activities can be addressed in their appropriate place during the product lifecycle, and when problems arise, they can be quickly rectified. Ultimately, the QMS can be used to help device manufacturers bring their products to market as much as five times faster and improve their ability to be effective solution providers.