mi-CE consultancy offers complete (including clinical) consultancy services for Medical Device and In Vitro Diagnostic Device manufacturers for CE marking compliances according to the MDD and IVDD. mi-CE also performs CE/Quality Managemen System compliance audits and design dossier/technical dossier review services for notified bodies and accrediation bodies.
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| Adres: | Kerkstraat 30A 6675 BS Valburg |
| Telefoon: | 0488-430190 |
| Fax: | 0488-430919 |
| Website: | www.mi-CE.nl |
| Email: | info@mi-CE.nl |
| Contactpersoon: | Mevrouw Anja Wiersma, PhD |
| KvK: | 50662473 |
| Producten / onderzoeksthema's: | Regulatory compliance services for medical devices, and in vitro diagnostics with thorough clinical evaluations, including set up of design history files/ technical dossier and full quality management systems; executed by fully qualified notified body auditors for MDD and IVDD Performance and reporting of several kinds of audits; 1) regulatory complaince audits, 2) QMS audits ISO 9001:2008, ISO 13485:2003 also under CMDCAS, 3) internal audits, 4)supplier/subcontractor audits, executed by fully qualified notified body auditors. Consultancy services regarding clinical pathway strategy and reviews, clinical trial design and evaluation; executed by Medical Doctors with a wide broad access to several clinical departments in leading hospitals. |
| Partners: | collaborations with innovative start-up companies; university high tech departments in the process of developing a product for market approval collaboration with small, medium size and large medical device and in vitro diagnostic device manufacturers |
| Werkgebied: | Wereldwijd |
