The creation of a DHF is the last step in the design controls process mandated by the FDA in 21 CFR Part 820. While the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards, the DHF is primarily an organizational tool meant to show that the ..
Category : Medical Device
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including In Vitro Diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle ..
A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use. It must be intended by the manufacturer to be used in vitro for ..
A robust DIOM can serve as the foundation for meeting FDA requirements and is a useful tool to ensure future iterations, changes, and re-visits to the initial design are clearly documented. A DIOM ensures design information is clearly presented, well-documented, and most importantly, located within one simple document. This webinar provides a simplistic tool to ..
International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. General tolerance ISO 2768 does not specify where to use these tolerances. Tolerance class is defined as per design requirements and manufacturing capability. For example ..
One way to think about guidance documents are as suggested opinions of best practices from the FDA. Guidance documents work hand-in-hand with the applicable regulations (21 CFR 812, 312, 50, 54, 56) to deliver recommendations of leading best practices to produce clinical research in a manner that protects patient’s rights, safety, and welfare while delivering ..
NCMR is an acronym for Non-conforming material report. When an item does not meet specifications it is identified as discrepant and an NCMR is created. A team meeting is held within the Material Review Board (MRB) to review discrepant items. The MRB consists of: Supplier Quality Engineer (SQE) Manufacturing Engineer (ME). Information required: Details of ..