WL39WWW634.WEBLAND.CH

CE+ Medical Devices | HOME

Zusätzliche Informationen zum Inhalt. Keyword bFreeHeading search not defined. We are looking for new team members. Medical devices include a variety of instruments, apparatus, equipment and materials as well as substance preparations or other items that are intended for medical purposes. Our company is based in Badenweiler, south of Freiburg, from where we operate as an international service provider for regulatory affairs of medical devices and IVD. With our dynamic “hands-on-mentality”...

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CE+ Medical Devices | HOME | wl39www634.webland.ch Reviews

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Zusätzliche Informationen zum Inhalt. Keyword bFreeHeading search not defined. We are looking for new team members. Medical devices include a variety of instruments, apparatus, equipment and materials as well as substance preparations or other items that are intended for medical purposes. Our company is based in Badenweiler, south of Freiburg, from where we operate as an international service provider for regulatory affairs of medical devices and IVD. With our dynamic “hands-on-mentality”...

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CE+ Medical Devices | HOME | wl39www634.webland.ch Reviews

https://wl39www634.webland.ch

Zusätzliche Informationen zum Inhalt. Keyword bFreeHeading search not defined. We are looking for new team members. Medical devices include a variety of instruments, apparatus, equipment and materials as well as substance preparations or other items that are intended for medical purposes. Our company is based in Badenweiler, south of Freiburg, from where we operate as an international service provider for regulatory affairs of medical devices and IVD. With our dynamic “hands-on-mentality”...

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CE+ Medical Devices | Medical Device

http://wl39www634.webland.ch/product-categories/medical-device

Zusätzliche Informationen zum Inhalt. Keyword bFreeHeading search not defined. IEC 62304 - Software life cycle processes. We were able to apply our knowledge during the last years in the following medical fields. A selection of non-active and active medical devices we supported on the way to reach marketing authorization:. Bull; Surgical Instruments. Bull; Surgical Implants. Bull; Electrical Devices. Bull; Wound patches. Bull; Substance based medical devices. Bull; Skin closure devices.

2

CE+ Medical Devices | Clinical Evaluation / Performance Evaluation

http://wl39www634.webland.ch/special-topics/clinical-evaluation-performance-evaluation

Zusätzliche Informationen zum Inhalt. Keyword bFreeHeading search not defined. Clinical Evaluation / Performance Evaluation. In Vitro Diagnostic Tests / Biological Safety. EN 62366 - Usability. Clinical / Performance Evaluation. You have developed a new medical device or an IVD? During the R&D work you have become a specialist for this indication and its technical solutions. But what about a Clinical investigation that should be accepted by the Notified Body? MEDDEV 2.7.1. MEDDEV2.14/2 rev. 1.

3

CE+ Medical Devices | About CE+

http://wl39www634.webland.ch/about-ce

Zusätzliche Informationen zum Inhalt. Keyword bFreeHeading search not defined. How to find us. CEplus is an international service provider for medical devices and in vitro diagnostics, based in Badenweiler, in the immediate vicinity of Freiburg and Basel. Our core competence is CE-marking. For the European market. Systems. We offer a broad range of activities in order to realize your market success. In doing so resources of our international network. Regulatory Affairs and More. 49 (0) 7632/822 69-0.

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CE+ Medical Devices | CE-marking

http://wl39www634.webland.ch/main-services/ce-marking

Zusätzliche Informationen zum Inhalt. Keyword bFreeHeading search not defined. Qualitymanagement - EN ISO 13485. Riskmanagement - EN ISO 14971. We have supported a huge variety of medical device and IVD manufacturers to meet the Directive requirements for CE-marking, granting market access into the European Union. Product classification and selection of suitable procedures for product conformity assessments. Compilation of Technical Documentation. Compliance check with Essential Requirements. Demarcation...

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wl39www634.webland.ch

CE+ Medical Devices | HOME

Zusätzliche Informationen zum Inhalt. Keyword bFreeHeading search not defined. We are looking for new team members. Medical devices include a variety of instruments, apparatus, equipment and materials as well as substance preparations or other items that are intended for medical purposes. Our company is based in Badenweiler, south of Freiburg, from where we operate as an international service provider for regulatory affairs of medical devices and IVD. With our dynamic “hands-on-mentality”...

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