ISO 13485 kvalitetsstyrningssystem för medicinska apparater

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The Medical Device Directive 93/42/EEC (MDD) lists the essential safety, efficacy and quality requirements that a medical device must meet in order to be CE marked and placed on the European market. 'If the appliance is at the same time a medical device within the meaning of Directive 93/42/EEC (*) and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this Directive. (*) OJ No L 169, 12. 7. 1993, p.

Covers all the medical products that are used in human body right from heart valves to scalps. CE/EC Certificate demonstrates that the manufacturer complies with the Medical Device Directive 93/42/EEC, that regulate the area of medical devices. EN ISO 13485:2016 standard applied by the manufacturers of medical devices to prove the compliance of the quality system with the requirements of MDD 93/42/EEC . This document supersedes EN ISO 13485:2003.

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The In common with other New Approach Directives, the three Medical Device Directives in place include provisions for mandatory CE Marking of all products covered Mar 28, 2019 In order to place a medical device on the EU market, it must meet essential ( AIMD); Directive concerning medical devices 93/42/EEC (MDD). CE conformity assessment procedures for RAUMEDIC medical devices in line with: Appendix II of EU Directive 93/42/EEC; Appendix 2 of EU Directive 90/385/ EEC. Our services for customized ISO Certificates. Certificate ISO 13485 [PDF].

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Audit of process according the requirements of ISO 9001, ISO 13485, MDD (93/42/EEC). Preparing QMS documentation of processes in according with the requirements of ISO 13485, ISO 14971, ISO 9001, ISO 19011, EN 62366, EN 62304, ISO 2859-1, EN 60601 - CE marking.

Dyrektywa Rady 93/42/EWG z dnia 14 czerwca 1993 r.
Vård av barn arbetsgivare

Lichtenstein) Europeiska kommissionen, Medical Device Directive 93/42, Tillgänglig:. CE designation in accordance with EC directive 93/42/EEC, class IIa. ISO 14971, ISO 13485, ISO 10993-1 and ISO 17510-2.

Modification: Directive 93/68/EEC [CE Marking] Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices EU 지침 93/42/EEC (Medical Devices Directive - MDD)는 제조사와 수입업자가 CE 인증을 신청하고 제품을 적법하게 시장에서 판매하기 위해 반드시 충족시켜야 하는 필수적인 요구사항들을 규정하고 있습니다. MDD 가 다양한 종류의 의료기기에 적용되고 있기 때문에, 특정 요구사항들은 제품의 분류와 사용목적에 따라 다르게 적용됩니다.
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Medicintekniska produkter enligt LVFS 2003:11; MDD 93/42

1993, p. 1.' 3.

Medicinska informationssystem - Svensk Medicinteknisk

Device Directive, IVD Directive 98/79/EC and Medical Device Directive, MDD 93/42 EEC. 2017/745 (Medical Device Regulation), IVDR 2017/746 (IVD Regulation), MDD 93/42 / EEC (Medical Devices), MDD 98/79 / EU (IVD), ISO13485: 2016 (QMS ) European Authorized Representatives of Medical Devices, EC REP, CE Mark in the European Medical Device Directives Medical Device Directive 93/42/EEC, Direktiv 90 / 385 / EEG: Aktiva implanterbara medicinska apparater; Direktiv 93 / 42 / EEG: Medicinska apparater; Direktiv 98 / 79 / EC: Diagnostiska medicinska BrainCool har även erhållit EN ISO 13485:2012 vilket är en international EC certifikatet (MDD 93/42/EEC Annex II) innebär att Brain Cool AB och och certifierats för att bolaget själva ska kunna CE-märka sina produkter, BrainCool har även erhållit EN ISO 13485:2012 vilket är en international EC certifikatet (MDD 93/42/EEC Annex II ) innebär att Brain Cool AB och och certifierats för att bolaget själva ska kunna CE-märka sina produkter, CE. AMON. 2460. EG - Försäkran om överensstämmelse CE. AMON. 2460. EC - Declaration of conformity.

ASTM D5250. • MDD 93/42/EEC. • MDR 2017/745/EU. • PPE 2016/425/EU. Ackrediteringar: • ISO 13485.