LINKS:

Obelis European Authorized Representative Center
European Authorized Representative & CE Marking
Obelis European Authorized Representative Center (O.E.A.R.C.) provides CE Marking regulatory compliance consulting to manufacturers worldwide, in accordance with European Directives such as MDD 93/42/EEC, IVD 98/89/EC , and Low Voltage Devices 73/23/EEC . Our high quality compliance solutions, proven by our ISO 9002 certification, include Commercial, Regulatory, Administrative, and Market Development Services through our Brussels, Belgium headquarters. Our worldwide regulatory solutions are provided through our global and professional One Link One Solution™ Network.

Translation Services
Net-Translators Ltd is a leading provider of Translation and Localization services over 40 languages. And specialize in Technical translation including Software localization, Medical translation in its' varied formats, Marketing collateral translation and Website translation services.

HIPAA Certification Training
HIPAA Certification Training, Contingency Plan Templates and Compliance
Consulting We deliver solutions like HIPAA Certification Training,
Security Risk Analysis/Assessment, HIPAA Contingency Plan, HIPAA Audit,
HIPAA training manuals and compliance consulting services. We also
provide Business Impact Analysis (BIA) templates, Risk Assessment
templates , Disaster Recovery Plan (DRP) templates and Business
Continuity Plan (BCP) templates.

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FDA Links and Guidance:

1) Food and Drug Administration (FDA)
      www.fda.gov
1.1) Small Business Guide
      www.fda.gov/ora/fed_state/Small_Business/sb_guide/default.htm
1.2) FDA Forms
      www.fda.gov/opacom/morechoices/fdaforms/fdaforms.html
1.3) Code of Federal Regulations
      (CFR Title 21 - Food and Drugs: Parts 1 to 1499)
      www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
2) Medical Devices-Center for Devices and Radiological Health
      www.fda.gov/cdrh/
2.1) Device Advice
      www.fda.gov/cdrh/devadvice/
2.2) Device Registration and Listing
      www.fda.gov/cdrh/reglistpage.html
2.3 ) Device Import/Export Issues
      www.fda.gov/cdrh/international/
3) Biologics-Center for Biologics Evaluation and Research
      www.fda.gov/cber/index.html
4) Drugs- Center for Drugs Evaluation and Research
      www.fda.gov/cder/index.html
5) Combination Products
      www.fda.gov/oc/combination/

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Accurate Consultants
Glen Feye, M.S., CQE
Principal Consultant