Integrating clinical research into the product development cycle

Medical Device and Diagnostic Industry

Volumn 23, Issue 5, 2001, Pages 150-157

  Stark, Nancy J ^a  

^a Clinical Design Group Inc

Author keywords

[No Author keywords available]

Indexed keywords

EID: 77449095802     PISSN: 0194844X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (5)

1. NJ Stark, "Claims," Chap. 3 in Project Management for Clinical Trials (Chicago: Clinical Design Group, 1999), 47-62.
2. 21 CFR, Part 812.1, "Investigational Device Exemptions, Scope."
3. 61 FR: 52619-52620, October 7, 1996.
4. The names device companies use to describe these studies-pilot, safety, feasibility, manufacturing-vary widely and the actual name is unimportant. The studies are characterized by a small sample size and a specific objective where the data are used to guide subsequent product development decisions.
5. 61 FR: 52618, October 7, 1996.