European Medical devices regulation

European Medical devices regulation

Opinion of the European Economic and Social Committee on the Pro European Parliament and of the Council on Medical Devices and amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 » COM (2012) 542 final - 2012/0266 (COD) to Proposal for a Regulation of the European Parliament and of the Council concerning medical devices in vitro diagnostic » COM (2012) 541 final - 2012/0267 (COD) and Communication from [...]

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Medical Devices Regulatory Affairs

Medical Devices Regulatory Affairs

Description :: Training: Train specialists in regulatory affairs and thus train qualified people in the medical device in the context of the new European regulation that aims to master 2. This master was created in collaboration between Lyon and Polytech ISPB (Institute of Pharmaceutical and Biological Sciences) and in synergy with the SNITEM (Nationnal Union Medical Technologies). Summary :: Training: The training is based on three core competencies: [...]

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GMP regulations Medical devices

GMP regulations Medical devices

The following content is for reference only; vendors handle cases when treated in accordance with the opinion of the contractor personnel. Question 1: Application of domestic medical equipment GMP evaluation What basic qualifications required? Reply: The vendor shall obtain registration certificate and manufacturing plant drug dealers license license, registration certificate and the address of the factory manufacturing drug dealers to be covered [...]

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Medical devices Regulations Part 1

Medical devices Regulations Part 1

Basic data of the Directive Title: Directive 93/42/EC of the European Parliament and of the Council of 14 June 1993 concerning medical devices Short title :: (Not official) Medical Devices Directive English: MDD (Medical Device Directive) Legal nature: Directive Scope: European Union Release: OJ. EC No. L 169, 12.7.1993 Adoption: 12th July 1993 Into national law implemented by: 1 July 1994 Implemented by: Medical Devices Act (Germany) on 2 August [...]

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