hi there,
Integrated process- following and implementing the CAPA (Corrective and Preventive Actions) is an important aspect that a medical manufacturing companies need to meet. This is not only about delivering innovative devices moreover catering medical devices that are high quality and risk free. Prioritize a continuous production of high quality product, standard customer satisfaction, attaining profitable margin and long-term goal planning.
Good Governance- as securing the health of the many by providing good quality of medical devices and equipment, a manufacturing firm must establish a governing body that assist the decision making in cost-benefit and risk-benefit analyses. Hence, this body must be particular in the effectiveness measures and practices.
Cross-Functional participation- proper management can ensure that all aspect re well-regulated and teamwork and alliance of work from the different department are necessary (regulatory, medical, Rand D, engineering and production).
Sufficient resources- adequate resources and tools are important in engaging to innovative modification of medical devices and preparation for post market examination. Developing numbers of resources and sustainable training can ensure excellence of work delivered to the client.
Hope this can help