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Medical Devices | Life Sciences | SGS

No matter the size of your organization, SGS’s medical device testing, certification, audit and training services can help you navigate the complexities of international medical device regulations to bring your products to market while ensuring compliance with the required regulations and standards and providing a high level of safety to patients and healthcare professionals.

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Apr 22, 2020 · AFNOR Releases General Purpose Mask Standard. The French association, AFNOR, has released AFNOR SPEC S76-001 “Masques barrières" or “Barrier Masks” (in English), a standard that establishes minimum requirements for non-medical general purpose masks. Next Article SGS Joins Oxford University Consortium to Develop COVID-19 Vaccine

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Face Mask Regulations and Standards in the EU: An Overview

Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face mask is supplied. The following information must be provided: a) number of this European Standard; b) Type of mask (according to the information in the table).

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SafeGuards – Regulatory Updates | SGS Korea

The new European medical devices legislation, MDR, should replace the current Medical Devices Directive from May 26, 2020. However, as a result of a lack of designated Notified Bodies, coupled with Brexit and COVID-19 pandemic the EU has proposed a one-year delay to the Date of Application.

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IEC | Industrial Manufacturing | SGS South Africa

As a designated National Certification Body (NCB) we can help you with the preparation of CB Test Reports and Certification enabling your products to demonstrate compliance to relevant standards across the IEC CB scheme countries. Meeting the relevant IEC specification improves safety and the marketability of your product.

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SGS has a wide range of tests and services to test medical devices. From hygienic qualification of production facilities to screening for possible redual contaminants (endotoxins, ethylene oxide), SGS can ensure that your medical devices and production environment are safe. Find out more now.

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