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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

  1. Constitution of the Republic of Bulgaria, Article 29 (1991)
  2. Oviedo Convention on Human Rights and Biomedicine (2001)
  3. Law Ratifying the Additional Protocol on Biomedical Research (2005)
  4. Law on Medicinal Products in Human Medicine (2007)
  5. Healthcare Act, Articles 199 and 200 (2007)
  6. Law for Medicinal Products in Human Medicine (2007), Chapter 4
  7. Personal Data Protection Act (2006)

  1. Regulation No. 31 on the Rules for GCP (August 12, 2007)

Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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