Medical OEMs can leverage the knowledge, experience, and documentation tools of an external designer/manufacturer as a competitive advantage. Truly sophisticated external manufacturing partners can be engaged to help outline the necessary V&V process at the inception of the project. This will ensure that the project plan, roles and responsibilities, and budget accurately reflect the needs and expectations of the OEM and the product/project as a whole.
MPE’s proven stage gate development process is a benefit most OEMs appreciate. These processes are managed by our PMP certified Project Management team. Their focus is on driving both the internal and external project teams to the agreed upon timeline and target price. They track every phase of the project from scope and requirement documents to sign-off approvals and testing documentation removing that burden from the OEMs diminished resources.
In order to focus on their core technology, many OEMs have experienced a reduction in internal V&V resources. Because V&V is crucial to compliance in an increasingly complex regulatory environment, it is more important than ever to leverage the expertise of external suppliers. When working closely with a strategic manufacturing partner, internal resources can assume a “review and approve” role as opposed to implementing time-consuming testing and validation tasks. Everyday exposure to industry requirements including IEC 60601, CE, and FDA allow external partners to design, engineer, and manufacture with extreme efficiency. With more efficient regulatory compliance, delays are eliminated and products are accelerated to market.