Using risk analysis to develop coated medical devices

Medical Device and Diagnostic Industry

Volumn , Issue JAN., 2005, Pages 33-40

  Triolo, Phil ^a  

^a Phil Triolo and Associates LC

Author keywords

[No Author keywords available]

Indexed keywords

EID: 27844581156     PISSN: 0194844X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (11)

1. Erik Swain, "Coatings: The Next Generation," Medical Device & Diagnostic Industry 25, no. 7 (2004): 70-77.
2. Design Control Guidance for Medical Device Manufacturers, [on-line] (Rockville, MD: FDA: CDRH, 1997); available from Internet: www.fda.gov/cdrh/ comp/designgd.html.
3. Harvey Rudolph, "Do We Need Medical Device Risk Management Certification?" Medical Device & Diagnostic Industry 24, no. 11 (2003): 44-49.
4. Mike W Schmidt, "The Use and Misuse of FMEA in Risk Analysis," Medical Device & Diagnostic Industry 25, no. 3 (2004): 56-61.
5. Shelf Life of Medical Devices, [on-line] (Rockville, MD: FDA: CDRH, 1991); available from Internet: www.fda.gov/cdrh/ode/415.pdf.
6. Recognition and Use of Consensus Standards; Final Guidance for Industry and FDA Staff, [on-line] (Rockville, MD: FDA: CDRH, 2001); available from Internet: www.fda.gov/cdrh/ost/guidance/321.html.
7. Draft Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers, Intravascular Stents, [on-line] (Rockville, MD: FDA: CDRH, 1995); available from Internet: www.fda.gov/cdrh/ode/846.pdf.
8. Preclinical Studies and Good Laboratory Practice, [on-line] (Rockville, MD: FDA: CDRH, 2003); available from Internet: www.fda.gov/cdrh/devadvice/ide/ related.shtml.
9. Memorandum G95-1: "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices," [on-line] (Rockville, MD: PDA: CDRH, 1995); available from Internet: www.fda.gov/cdrh/g951.html.
10. Early Collaboration Meetings Under the PDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff, [on-line] (Rockville, MD: FDA: CDRH, 2001); available from Internet: www.fda.gov/cdrh/ode/guidance/310.html.
11. The New 510(k) Paradigm-Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications-Final Guidance, [on-line] (Rockville, MD: FDA: CDRH, 1998); available from Internet: www.fda.gov/cdrh/ode/parad510. html.