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ASTM PACKAGING - ASTM PACKAGING STANDARDS AND RELATED TECHNICAL MATERIAL
ASTM
A description is not available for this item.
MEDDEV 2.7/1 - GUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC
June 1, 2016
- EU/EC
A description is not available for this item.
EEC/2016/679 - REGULATIONS OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation)
April 27, 2016
- EU/EC
A description is not available for this item.
EEC/2014/34 - DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (recast)
February 26, 2014
- EU/EC
A description is not available for this item.
MEDDEV 2.12/1 - GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
January 1, 2013
- EU/EC
A description is not available for this item.
MEDDEV 2.14/1 - GUIDELINES ON MEDICAL DEVICES IVD Medical Device Borderline and Classification issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
January 1, 2012
- EU/EC
A description is not available for this item.
MEDDEV 2.12/2 - POST MARKET CLINICAL FOLLOW-UP STUDIES A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
January 1, 2012
- EU/EC
A description is not available for this item.
MEDDEV 2.5/10 - GUIDELINE FOR AUTHORISED REPRESENTATIVES
January 1, 2012
- EU/EC
A description is not available for this item.
MEDDEV 2.1/6 - GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES
January 1, 2012
- EU/EC
A description is not available for this item.
MEDDEV 2.7/4 - GUIDELINES ON CLINICAL INVESTIGATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
December 1, 2010
- EU/EC
A description is not available for this item.
MEDDEV 2.7/3 - GUIDELINES ON MEDICAL DEVICES CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING UNDER DIRECTIVES 90/385/EEC AND 93/42/EEC.
December 1, 2010
- EU/EC
A description is not available for this item.
MEDDEV 2.4/1 - GUIDELINES RELATING TO THE APPLICATION OF THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES
June 1, 2010
- EU/EC
A description is not available for this item.
EC 2010/30/EU - DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the indication by labelling and standard product information of the consumption of energy and other resources by energy-related products
May 19, 2010
- EU/EC
A description is not available for this item.
MEDDEV 2.7.1 - GUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
December 1, 2009
- EU/EC
The primary purpose of this document is to provide manufacturers and notified bodies with guidance on how to conduct and document the clinical evaluation of a medical device as part of the conformity assessment procedure prior to placing a medical device on the market as well as to support its...
MEDDEV 2.1/3 - GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES
December 1, 2009
- EU/EC
A description is not available for this item.
MEDDEV 2.15 - GUIDELINES ON MEDICAL DEVICES Committees/Working Groups contributing to the implementation of the Medical Device Directives
December 1, 2008
- EU/EC
A description is not available for this item.
MEDDEV 2.7.2 - GUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN MAKING AN ASSESSMENT OF CLINICAL INVESTIGATION NOTIFICATION
December 1, 2008
- EU/EC
A description is not available for this item.
MEDDEV 2.11/1 - GUIDELINES ON MEDICAL DEVICES APPLICATION OF COUNCIL DIRECTIVE 93/42/EEC TAKING INTO ACCOUNT THE COMMISSION DIRECTIVE 2003/32/EC FOR MEDICAL DEVICES UTILISING TISSUES OR DERIVATIVES ORIGINATING FROM ANIMALS FOR WHICH A TSE RISK IS SUSPECTED
January 1, 2008
- EU/EC
A description is not available for this item.
MEDDEV 2.14/3 - GUIDELINES ON MEDICAL DEVICES IVD GUIDANCES: Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
January 1, 2007
- EU/EC
A description is not available for this item.
