Scientists who are unaccustomed to oversight benefit from operational support such as report templates. 
Non-experimental study
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Human Performance Technology (HPT) extends Human Factors studies by considering four factors influencing performance driven by the desired function: 1) Information — does the person have it and should it reside internally or externally; 2) Environment — how design of systems, devices and work processes help or hinder performance; 3 Selection — does the person have the requisite abilities; 4) Motivation — are there clear goals and feedback mechanisms. These issues are important to the end-user/customers; to the manufacturers and to regulatory bodies such as the FDA.
Medical Device Industry experience.
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Regulatory bodies in different nations have different requirements and different approaches to specific tests. It is possible and helpful to identify a global submission strategy that can, at least partially, be used for several nations or global regions. It is particularly important to interact with regulatory personnel to stay up to date on current regulatory requirements.
Case studies and author experience.
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Supply contracts for materials and components should be confirmed early in the validation or testing stage. This is particularly important when product performance or regulatory acceptance testing will require a significant portion of the project's time line and resources.
Conclusions drawn from case studies and experience.
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Testing in the Medical Device Industry: Medical devices are classified according to the level of control that is necessary to ensure the safety and effectiveness of the device during its intended use. The U.S. FDA and the European Medical Device Directive identify three classes, with Class III requiring the greatest control.
Case studies and author experience.
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To obtain clearance or approval to market and sell a medical device, the manufacturer must provide the Notified Body with all information necessary for proper assessment of the device's conformity to specified requirements.
Case studies and author experience.
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Product launches into international markets often schedules sequence of launches into the various markets, because of supply limitations, regulatory differences, and the variation in drivers within each market segment.
Conclusions drawn from case studies and experience.
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Significant innovations are likely to emerge from a combination of complimentary skills
Source: Glaister, 1996. In: Emden, Z., Calantone, R.J. & Droge, C. (2006)