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Wireless terminals, such as 5G, LTE, GSM & GPRS, CDMA, WLAN, Bluetooth, and WCDMA, including cell phones and other mobile devices, emit radio frequency energy. Strong electrical and magnetic radiation has been proven to be harmful to ...

In the past, a vehicle battery was considered to be a more or less handy and portable component that provided the 12/24 V voltage for the vehicle. In the context of electromobility, this has not only changed fundamentally in terms of battery technology, but the traction battery today has a size ...

The EN IEC 62368-1 standard defines safety requirements for audio/video, information, and ...

SGS Fimko Oy is designated as Notified Body for Medical Device Regulation (EU) 2017/745 by the Finnish competent authority FIMEA. Download Notification by Finnish Medicins Agency The notification includes following conformity assessment routes (regulation (eu) ...

Die SGS Fimko Oy ist durch die finnische Behörde FIMEA als Benannte Stelle für die Medizinprodukteverordnung (EU) 2017/745 benannt. Download Benennungsurkunde Finnish Medicins Agency Folgende Konformitätsbewertungsverfahren sind in die Benennung eingeschlossen (Verordnung ...

E-bikes and pedelecs are becoming increasingly popular as an alternative to using a car and must meet high legal ...

Do you want to have your medical device tested and certified according to MDR and don’t want to be slowed down by long waiting times? Or are you, as a manufacturer of medical devices, considering changing your Notified ...

With its extensive accreditation scope, SGS covers a variety of product safety standards for lamps, luminaires, and LEDs in its service ...

In almost all markets around the world, product safety requirements (including burning and flammability) for lamps, luminaires, and LEDs are regulated ...

The laboratory of SGS Germany GmbH in Munich on Hofmannstrasse is currently moving to the new location in Puchheim, on Benzstrasse in the west of Munich. Specifically, this affects the accredited testing areas of electromagnetic ...

Do you want to have your medical device certified according to MDR and don’t want to be slowed down by long waiting times? Or as a medical device manufacturer, are you considering changing your Notified Body? With our Notified Body SGS Fimko Oy (NB ...

We are happy to announce that the Notified Body SGS Fimko (CE0598) has issued an MDR certificate for its first client in Germany. Gründler GmbH in Freudenstadt (Baden-Württemberg) is the manufacturer of the innovative medical product Ventilution®. This ...

International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators around the world, established in 2011, and builds on the foundational work of the Global Harmonization Task Force ...

The Medical Device Coordination Group (MDCG) has published a new guidance document MDCG 2023-3 entitled “Questions and answers on ...

Auch 2023 stellen wir mit unseren Fachexperten Armin Hudetz, Josef Bauer, Markus Spiel und Michael Sperling vom 28. bis 30.03. auf dem EMV-Kongress in Stuttgart interessante Workshops vor. In diesem Jahr bieten wir Ihnen drei Beiträge an: 1.) EMV, Funk ...

The list of harmonized standards under Medical Device Regulation (EU) 2017/745 was amended with the latest normative documents concerning respiratory devices and sterile medical products. The deadline for adoption of the standards by the ...

The United States General Services Administration has recently announced that the FDA will update the existing Quality System Regulation for medical devices with the requirements of ISO 13485:2016: View publication. This update will harmonize ...

The Medical Device Coordination Group (MDCG) recommends all MDR Notified Bodies to disclose their list of standard fees. “They should be directly and easily accessible on the website of the Notified Body without any additional steps,” says the new MDCG 2023-2 ...

On January 6, 2023, the EU Commission adopted a proposal to allow more time to certify medical devices according to Regulation (EU) 2017/745. This decision is aimed at mitigation of the risk of medical devices’ shortages. For many manufacturers the ...

The European Commission has published two new documents, which detail the rules on EU market access for manufacturers of devices without medical intended purpose listed in Annex XVI of MDR. Common specifications (CS) for skin treatment ...