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Medical Devices (active/non-active)
Quality is vital – trust us. Are you looking for a partner who provides reliable support? Then come to us – we are a “Notified Body” for all medical devices and in-vitro diagnostics. We certify products and QM systems for the European and international market. We provide you with experience, expertise and service.
CE conformity for active and non-active medical devices.
Service at a glance
As a manufacturer you must declare the conformity of your medical devices with the requirements of the EU-directive 93/42/EEC for active and non-active medical devices with the CE-mark. Depending on the product’s risk category, the involvement of a “Notified Body”, which you commission for example with the conducting of an EC type-examina-tion, the assessment of a design dossier or the auditing of your QM system, is absolutely essential.
In cooperation with you, we conduct the necessary compliance assessment procedures for your devices and your company. You are thus quickly provided with your “admission ticket” to the countries of the EU.
We are pleased to offer you testing of special and voluntary market requirements as well.
CE conformity for in-vitro diagnotics
We are also a “Notified Body” for the field of in-vitro diagnostics (IVD). You can have your devices tested and certified by us in accordance with the various procedures of the European IVD Directive 98/79/EC.
CE conformity for active implantable medical devices
For the testing and certification of active implantable medical devices (AIMD) the EU directive 90/385/EEC needs to be the basis. Here, the commission of a “Notified Body” is a necessity, impartial of the product’s risk category.
Also in questions about Ergonomics and Electromagnetic compatibility (EMC) of medical devices we are the right contact.
Simply give us a call – We look forward to hearing from you!