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QNET's IVD experts can assist you in complying with the In-vitro Diagnostic Device Directive 98/79/EC.
Our affordable and practical approach to CE Marking of In Vitro Diagnostic Devices in accordance with the self-certification route for low risk devices not covered by List A or B of Annex II meets the needs of small/medium size manufacturing companies that export to the European Union.
This CE-Marking service consists of:
- Review of the required Quality Assurance System as appropriate for the products manufactured.
- Organizing and preparation of the technical documentation consisting of building a technical file that keeps documentation to a minimum.
- Office for Regulatory Affairs in Europe that deals with the Competent Authorities on the company's behalf.
Contact us for more info
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