News Archives - Page 86 of 86

The paper at the link provided was written by Mark Paulk of the SEI. It compares ISO 9001 and the Capability Maturity Model (CMM). Although there are some differences between ISO 9001 and the FDA Quality System Regulation, both in content and enforcement, this paper may be helpful for medical device software developers involved in...

Mar

FDA CBER 1994 BECS Manufacturer Letter

March 31, 1994Alan KusinitzNews

/docs/CBER-BECS510kLetter1994.pdf

Oct

Inhalers, Spacers FDA CDRH 510(k) Nebulizers

October 1, 1993Alan KusinitzNews

http://www.fda.gov/cdrh/ode/784.html

Sep

Guideline for Val of Blood Establishment Computers

September 28, 1993Alan KusinitzNews

http://www.fda.gov/cber/gdlns/bldestcomp.htm

Aug

FDA CDRH 510(k) Guidance for PACS – OBSOLETE

August 1, 1993Alan KusinitzNews

/docs/PACSguidance.pdf

Mar

FDA CDRH 510(k) External Infusion Pumps

March 1, 1993Alan KusinitzNews

http://www.fda.gov/cdrh/ode/odegr823.html

May

FDA Device GMP Guidance: Computerized Devices

May 1, 1992Alan KusinitzNews

/docs/fdagmpcomputerinspectionguide1992.pdf

Sep

FDA CDER/ORA CPG 7132a.11 Software as Records

September 4, 1987Alan KusinitzNews

/Docs/7132a-425-100.pdf

Sep

FDA CDER/ORA CPG 7132a.12 Vendor Responsibility

September 4, 1987Alan KusinitzNews

/Docs/7132a-425-200.PDF

Sep

I/O Checks FDA CDER/ORA CPG 7132a.07 Monitoring

September 4, 1987Alan KusinitzNews

/Docs/7132a-425-400.PDF

Jul

FDA Technical Reference on Software Development

July 1, 1987Alan KusinitzNews

/docs/fdaswtechnicalreference1987.pdf

Apr

FDA CDER/ORA CPG 7132a.15 Source Code

April 16, 1987Alan KusinitzNews

/Docs/7132a-425-300.PDF

Apr

FDA CDER/ORA CPG 7132a.08 Computerized ID

April 16, 1987Alan KusinitzNews

/Docs/7132a-425-500.PDF

Mar

MIL-STD-882B System Safety Program Requirements

March 30, 1984Alan KusinitzNews

/docs/militarystandard-safety.PDF

Feb

FDA CDER Inspection of Computer Systems

February 1, 1983Alan KusinitzNews

/Docs/FDAdrugswguidanceFeb1983.pdf

Mar

Cl II Simens syngo Dynamics PACS

March 1, 1970Amy SellersNews

Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:3/26/2014 Class lI: PRODUCT syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 Recall Number Z-1216-2014 REASON Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one...

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FDA guideline for QA in blood establishments

FDA CDRH Draft Ventilator 510(k) Guidance

FDA Intel Pentium Problem Letter

NISTIR 5589 Study on Haz Analysis SW Stds & Gdlns

FDA CDRH 510(k) Galvanic Skin Response

FDA CDRH 510(k) Guidance for Tens 510(k) Content

FDA CDRH 510(k) Biofeedback Devices

FDA CDRH 510(k) Draft Version Neuro Endoscope

Comparison of ISO 9001 to the CMM

FDA CBER 1994 BECS Manufacturer Letter

Inhalers, Spacers FDA CDRH 510(k) Nebulizers

Guideline for Val of Blood Establishment Computers

FDA CDRH 510(k) Guidance for PACS – OBSOLETE

FDA CDRH 510(k) External Infusion Pumps

FDA Device GMP Guidance: Computerized Devices

FDA CDER/ORA CPG 7132a.11 Software as Records

FDA CDER/ORA CPG 7132a.12 Vendor Responsibility

I/O Checks FDA CDER/ORA CPG 7132a.07 Monitoring

FDA Technical Reference on Software Development

FDA CDER/ORA CPG 7132a.15 Source Code

FDA CDER/ORA CPG 7132a.08 Computerized ID

MIL-STD-882B System Safety Program Requirements

FDA CDER Inspection of Computer Systems

Cl II Simens syngo Dynamics PACS

62304 Software Training Course – February 23-25, 2021

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62304 Software Training Course – February 23-25, 2021

Subscription Services

Corporate Office