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JASA KONSULTAN SERTIFIKASI CE MARK

CE MARKING CONSULTING

ce-dp

Klausul Ce Mark

Semangkin tinggi dan maju sebuah peradapan manusia maka semangkin tinggi juga tingkat kesadaran akan keselamatan hidupnya khususnya dari pengaruh radiasi serta ketercemaran lingkungan dari bahan-bahan yang di gunakan oleh manusia itu sendiri. misalnya dari ketercemaran atau radiasi dari bahan eloctronic, misalnya: dari alat2 kesehatan, mainan anak dan LCD TV, dan lainnya.

Untuk mencegah itulah dunia eropa menciptakan sebuah standard yang harus di ikuti oleh setiap produsen atau pabrik penghasil barang2 yang di curigai mengandung radiasi yang merusak kesehatan manusia. berikut ini kami share klausul atau containt yang harus di implementasikan dalam proses produksi;

CONTENTS CE MARK

1. Introduction to the guide
2. Regulation
2.1. European directives regarding medical devices / In VitroDiagnostic medical devices and their consequences for placing on the market in the European Economic Area .
2.1.1. General
2.1.2. Scope of the directives
2.1.3. Essential requirements
2.1.4. Importance of standards and their use
2.1.5. Problems of interpretation
2.1.6. Coordination of Notified Bodies
2.2. Other directives to the taken into consideration where applicable
3. With LNE / G-MED, how do you obtain the certificates required for CE marking ?
3.1. Identification of the manufacturer and, where applicable, of the other parties
3.2. Characterization of the products concerned
3.3. Determining the applicable directive or directives
3.4. Determining the class of the device (Directive 93/42/EEC case)
3.5. Choice of the conformity assessment procedures
3.5.1. Assessment procedures for directives 90/385/EEC (AIMD) and 93/42/EEC (ce mark medical devices)
3.5.1.1. Examination of design (Annex II section 4)
3.5.1.2. EC type examination (Annex III)
3.5.1.3. Full quality assurance system (Annex II)
3.5.1.4. EC verification (Annex IV)
3.5.1.5. Production quality assurance (Annex V)
3.5.1.6. Product quality assurance (Annex VI)
3.5.1.7. DEcleration of comfermity ( annex VII )
3.5.1.8. Particular case of software

3.5.2. Assessment procedures for directive 98/79/EC (in vitro diagnostic medical devices)
3.5.2.1. Design examination (Annex IV section 4)
3.5.2.2. EC type examination (Annex V)
3.5.2.3. Full quality assurance system (Annex IV without sections 4 et 6)
3.5.2.4. EC verification (Annex VI)
3.5.2.5. Production quality assurance (Annex VII)
3.5.2.6. Product quality assurance
3.5.2.7. EC declaration of conformity (Annex III without section 6)
3.5.2.8. Verification of manufactured products
3.5.2.9. Particular case of software
3.6. Horizontal themes
3.6.1. Risk analysis
3.6.2. Clinical evaluation
3.6.2.1. Guiding principles
3.6.2.2. Practical approach
3.6.2.2.1. The notion of “clinical data” is pointless :
3.6.2.2.2. Clinical evidence is obviously acquired from the start :
3.6.2.2.3. The manufacturer provides sufficient data taken from the literature
3.6.2.2.4. The data consist of a clinical review.
3.6.2.2.5. Data from the literature are not available, or not sufficient :
3.6.2.2.5.1. Compliance with the regulation relating to the conduct of the clinical investigation
3.6.2.2.5.2. Pre-clinical data and contents of the clinical investigations plan
3.6.2.3. Examination of clinical data
3.6.3. Devices placed on the market in sterile condition
3.6.3.1. first possibility
3.6.3.2. Second possibility :
3.6.4. Establishing biocompatibility
3.6.5. Establishing microbiological safety
3.6.6. Devices with a measuring function
3.6.7. Devices that incorporate medicinal drugs
3.6.8. Device previously considered as medicines for placing on the market
3.7. Course of the procedure with LNE / G-MED
4. CE marking
5. Maintaining the advantage of CE marking
5.1. Full quality assurance system
5.1.1. Where product design examination has been carried out
5.1.2. General case
5.2. Production quality assurance
5.3. Product quality assurance
5.4. EC type examination
5.5. EC verification
5.6. EC declaration of conformity
5.7. Verification of manufactured products

Beberapa negara di dunia khususnya negara eropa mempersyaratkan bahwa sebelum masuk ke CE marking, maka organisasi atau perusahaan harus terlebih dahulu lulus ISO 9001.

Servis lain yang kami berikan, misalnya; Studi kelayakan, penyusunan laporan keuangan,  training, stangard gmp untuk pabrik kosmetik, hse untuk tender,  konsultasi sertifikasi iso 27000, for detail JASA KONSULTAN SERTIFIKASI CE MARK, pls contact us at:

ce consulting and training

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