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Regulatory Affairs
Top pick 21 CFR (Code of Federal Regulations Title 21) search
Top pick 21 CFR Part 800 (Code of Federal Regulations Title 21 Part 800) Medical Device
Top pick CDRH (Center for Devices and Radiological Health) web site
  CDRH Manual for the Good Guidance Practices (GCP) Regulations
  Determination of Intended Use for 510(k) Devices - Guidance for Industry and CDRH Staff
Top pick Device Advice CDRH self service medical device and radiation emitting product information
  Do It By Design — An Introduction to Human Factors in Medical Devices
  FDA Freedom of Information Reading Room
  FDA Medical Device Software Validation
  FDA MedWatch Safety Information and Adverse Event Reporting Program
  Frequently Asked Questions on the New 510(K) Paradigm
  Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
  Human Factors Points to Consider for IDE Devices
Top pick Index of Center for Devices and Radiological Health (CDRH) Web Documents
  Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
  Medical Device Quality System Manual
  Premarket Approval Manual
  Premarket Notification 510(k): Regulatory Requirements for Medical Devices
  Premarket Notification Review Program
Top pick Small Manufacturers Assistance (DSMA) web site
Medical Device Labeling
  Device Labeling Guidance
  Guidance on Medical Device Patient Labeling
  Human Factors Principles for Medical Device Labeling
  Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)
  Labeling Requirements
  Medical Device Labeling suggested format and content
  Write it Right
CE Mark Resources & Related Links

Sources for Ordering Standards in the USA

  American National Standards Institute (ANSI)
11 West 42nd Street, 13th Floor
New York, NY 10036
Phone: 212-642-4900
E-mail: info@ansi.org
  British American Chamber of Commerce
41 Sutter Street, #303
San Francisco, CA 94104
Phone: 415-296-8645
E-mail: info@baccsf.org
  Customs Standards Services, Inc.
802 Oakland Avenue, Suite 5
Ann Arbor, MI 48104
Phone: 800-699-9277 or 313-930-9277
E-mail: service@cssinfo.com
  Document Center
1504 Industrial Way, Unit 9
Belmont, CA 94002
Phone: 415-591-7600
E-mail: info@doccenter.com
  Document Engineering Co., Inc.
15210 Stagg Street
Van Nuys, CA 91405
Phone: 800-645-7732 or 818-782-1010
E-mail: doceng@doceng.com
  Euroconsult, Inc.
P.O. Box 243
Manchester, MA 01994
Phone: 508-526-1687
E-mail: euroconsult@shore.net
 

Global Engineering Documents
15 Inverness Way East
Englewood, CO 80112-5704
Phone: 800-854-7179 or 303-397-7956
E-mail: global@ihs.com

  ILI Infodisk, Inc.
The Plaza Building
14-25 Plaza Road
Fair Lawn, NJ 07410
Phone: 201-703-8418
  QSI-Qualified Specialists Inc.
323 North Belt, Suite 630
Houston, TX 77060
Phone: 800-856-5366 or 281-448-5622
E-mail: qsiinfo@isoconsultants.com
  Simcom International
6111 Peachtree Dunwoody Road
Building 3, Suite 200
Atlanta, GA 30328-4577
Phone: 770-730-9980
E-mail: simcom@cemark.com
  Standards Sales Group
15885 Main Street, Unit 250
Hesperia, CA 92345-3403
Phone: 619-947-6100
E-mail: 105114.3370@compuserve.com
  SWBC America, Inc.
4938 Hampden Lane #226
Bethesda, MD 20814
Phone: 301-656-9125
E-mail: SWBCusa@aol.com

Related Links

  American National Standards Institute (ANSI)
E-mail: info@ansi.org
  British Standards Institution
  CEN the European Committee for Standardization
  CENELEC the European Committee for Electrotechnical Standardization
  ETSI the European Telecommunications Standards Institute
  Europa the European Union Server
  Lovdata Foundation the host for the English version of Celex, the legal information system of the European Union.
  Medical Devices Agency
  National Center for Standards and Certification Information (NCSCI) provides information on U.S., foreign, and international voluntary standards; government regulations; and rules of conformity assessment for non-agricultural products.
  New Approach standardization in the European internal market

USA Export Information

  Trade Information Center for basic export information and country specific counseling
Phone: 800-USA-TRADE
  Bureau of Export Administration for export licensing information
  US Department of Treasury for embargo information
  US Department of State for travel advisories
  Census Bureau for harmonized/schedule B listing
  Trade Compliance Center for information on trade agreements and compliance issues

 

Medical Device Software Resources & Related Links
  Levkoff, B., Increasing Safety in Medical Device Software. Medical Device & Diagnostic Industry magazine, Canon Communications, September 1996.
  Niehoff, K., Software and FDA. Medical Device & Diagnostic Industry magazine, Canon Communications, January 1996.
  Suzuki, J. and D. W. Karolak. Software Risk Management: Not Just for the Big Manufacturers? Medical Device & Diagnostic Industry magazine, Canon Communications, June 1997.
  Suzuki, J. K., Documenting the Software Validation of Computer-Controlled Devices and Manufacturing Processes: A Guide for Small Manufacturers. Medical Device & Diagnostic Industry magazine, Canon Communications, January 1996.
  Vicens, C. F., Implementing an Automated Traceability Mechanism for Medical Device Software. Medical Device & Diagnostic Industry magazine, Canon Communications, February 1996.
  Wood, B. J., Software Risk Management for Medical Devices. Medical Device & Diagnostic Industry magazine, Canon Communications, January 1999.

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Updated 22-Mar-2003

 

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