Meddev 2 12
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EUROPEAN COMMISSION DG Health and Consumers (SANCO ...
meddev.infoMEDDEV 2 12-1 rev. 8 Vigilance 6 d) devices that do not carry the CE-mark but where such INCIDENTs lead to CORRECTIVE ACTION(s) relevant to the devices mentioned in a), b) and c). These guidelines cover FIELD SAFETY CORRECTIVE ACTION relevant to CE-marked devices which are offered for sale or are in use within the EEA, Switzerland and Turkey. ...
The top ten changes in MEDDEV 2.7.1 Rev 4 - BSI Group
www.bsigroup.comMEDDEV 2.7.1 Revision 4 has been released MEDDEV 2.7.1 Rev 4: Key changes and clarifications BSI MEDDEV 2.7.1 Rev 4 top 10 changes Call us now on +44 345 080 9000 Clarification: Frequency of updates to the Clinical Evaluation Report (CER). Clause 6.2.3 requires the CER to be updated at least annually for high risk or new devices, and every 2 to ...
Guidance MEDDEVs - European Commission
ec.europa.euMEDDEV 2.10/2 rev.1 (105 kB) Designation and monitoring of notified bodies within the framework of EC directives on medical devices annex 1 (119 kB), annex 2 (14 kB), annex 3 (16 kB), annex 4 (26 kB) April 2001 2.12 Post-Market surveillance . MEDDEV 2.12/1 rev.8 (763 kB) Guidelines on a medical devices vigilance system . January 2013
Effective post-market surveillance - BSI Group
www.bsigroup.comPMS NBMed 2.12 Vigilance MEDDEV 2.12-1 Post-market clinical follow-up MEDDEV 2.12-1 Reactive PMS Proactive PMS Proactive Reactive • Customer surveys • Post CE mark clinical trials, including PMCF • Manufacturer sponsored device tracking/implant registries • Expert user groups (focus groups) • Customer complaints
MEDICAL DEVICES Guidance document Classification of ...
www.meddev.infoFor further guidance on clinical evaluation see MEDDEV 2.7.1 Rev.34. Pursuant to article 15.1, in case of devices intended for clinical investigations, the manufacturer shall notify the Competent Authorities of the Member States in which the investigations are to be conducted in accordance with section 2.2 …
醫電設備電性安全測試與相關 法規實務
www.bmes.org.twIEC 60601-2- Nerve and Muscle Stimulators (12/87), Am.1 (09/01), Corrigendum (02/02). 10: IEC 60601-2-6 Microwave Therapy Equipment (01/84). IEC 60601-2-5 Ultrasonic Therapy Equipment (01/84), Ed.2 (07/00) IEC 60601-2-4 Cardiac Defibrillators and Cardiac Defibrillator-Monitors (01/83), Ed.2 (08/02), IEC 60601-2-3 Short-Wave Therapy Equipment Ed ...
Essential Requirements Checklist - Medical Device Academy
medicaldeviceacademy.com7.2 The devices shall be designed, manufactured and packaged in such a way as to minimize the risk posed by contaminants and residues to patients, taking account of ... 31.12.2008, p.1), and to substances having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health and which are ...