US Market Access
FDA 510 Registration
EU Market Access
CE Marking of European product compliance
Asia & China Market Access
- CE Marking for Medical Devices (EU Market access)
- CFDA for Medical Devices (Chinese Market access)
- FDA for Medical Devices (US Market access)
- Free quality support
- Fair pricing
- Determine applicable EU Directives, Regulations, standards and responsibilities of manufacturers, importers and distributors
- Private label for Medical Device products, OEM
- Medical Device Export to China
- Full CE certification support in order to achieve compliance with EU Product Safety legislation
- European Authorised Representation for manufactures and importers
- Expertise and consultancy on legal and technical issues in the field of European product legislation
- Mediation, expert determination and regulatory affairs with governments bodies in all EU Member States.
We assure compliance for the following products
Our expertise is based on a combination of practical and theoretical knowledge in Medical Device product safety, engineering, quality assurance, technical documentation and the use of test facilities.
CE Marking Medical Device
Medical Device products must be CE marked before they can be legally put into use in Europe. The products must comply with the European CE marking Directives such as Medical Device Directive (MDD) 93/42/EEC or In-Vitro Diagnostic Medical Devices (IVDD) 98/79/EC and Active Implantable Medical Devices (AIMDD) 90/385/EC. CE Medical has expertise in all procedures required to arrive at a successful CE marking certification and offers full assistance to gain the CE Mark of your Medical Device products.
CE Medical, in partnership with Certification Experts BV, is a technical and legal certification company specialized in CE and CFDA of Medical Devices.
There are 4 easy ways to contact us!
- Call us: +31 (0)294 41 75 81
- E-mail us: email@example.com
- Request a call back
- Fill in our contact form