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Design Control
We have been practicing design controls since the 1980’s, long before the introduction of these practices which are now part of modern-day development. Our deep-rooted knowledge and expertise gives us an edge over competitors.
Per FDA’s guidance document: “Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances. Design controls make systematic assessment of the design an integral part of development. As a result, deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected earlier in the development process. Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use”
These now required industry practices have always been part of our methods and processes and have been refined over the many decades of use. The result is a streamlined approach that does not sacrifice quality and an application of risk methods to determine how to execute design and testing. Not everything requires the same level of scrutiny – Pivotal brings you this expertise.
Pivotal’s phased design process activities are shown below:
Development Process
Phase Development
Why do this?
FDA introduced design controls 30+ years ago and set the standard for what is acceptable. International standards followed closely with the same intent under Medical Devices Directive (MDD 93/42/EEC). Between FDA’s guidance document, ISO 13485 the quality standard and other standards, we have a plethora of regulations to understand and apply. This is where Pivotal collaborates with their clients to take a streamlined, effective and result oriented approach.
