We offer US manufacturers assistance with CE marking of Medical Devices, IVDD, machinery, PED, PPE and ATEX. We also specialize in FDA 510(k) preparation and submission for US and non-US manufacturers. QNET BV is established in the Netherlands and acts as an EU Authorized representative for US Manuafcturers of CE marked medical devices, IVDD, machinery, PED, PPE, and ATEX. Below is a comprehensive list of services. Please contact us for more info
What We Do
- CE mark technical file for Medical Device Directive 93/42/EEC.
- CE mark technical file for IVD Directive 98/79/EC.
- CE mark technical file for Personal Protective Equipment directive 89/686/EEC.
- CE mark technical file for Pressure Equipment directive 97/23/EC.
- CE mark technical file for machinery directive 2006/42/EC.
- CE mark technical file for ATEX (Equipment for Explosive Atmospheres) directive 94/9/EC.
- FDA 510(k) preparation and submission.
- Europpean Authorized Representative Service.
QNET's experienced medical device experts deliver consultancy to comply with the Medical Device Directive 93/42/EEC, IVD Directive 98/79/EC, Personal protective equipment 89/686/EEC. Technical Files are written with the use of templates, checklists and a 'real time' vigilance manual for all risk class devices.
European registered design engineers write product specific ce mark technical files to comply with the machinery directive 2006/42/EC, PED directive 97/23/EC.
We have engineers specializing in compliance with ATEX directive (Equipment for explosive atmospheres) 94/9/EC. Please contact us for more info.