Our Services
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.
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.
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.
- 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.