The burden on quality and operations leaders to introduce compliant and innovative medical devices to market is great. And as regulatory standards, market requirements, and device complexities have evolved, so too has the weight of the burdens these leaders face.
“Monitoring and measuring product and process performance are key requirements of medical device regulations.”
– An Nguyen, Director of Regulatory Affairs & Quality Assurance, IntraOp
Unfortunately, traditional tools and staid approaches have not sufficiently lightened the load. Instead, they inadvertently add to it by promoting three key problems:
- Disconnected quality and product records
- Persistent silos of quality, engineering, operations, and related product teams
- Adoption of static methods to manage complex quality processes
Medical device manufacturers must overcome these issues to eliminate new product development (NPD) and new product introduction (NPI) process delays, reduce compliance risks, and remove barriers that impede innovation.