Dekra Certification BV

DEKRA Certification B.V. – Business Line Medical is a leading top 5 global Notified Body in medical device certification and recognized market leader in high risk devices. Our core business entails risk reduction & performance improvement by testing and certification of medical devices, and auditing of medical device companies.
As your Notified Body for worldwide Certification of Innovative Medical Devices and In-Vitro Diagnostic Devices, DEKRA Certification B.V. can offer you:
- Market Access:
EU Market Access to / Notified Body for: AIMDD 90/385/EEC, MDD 93/42/EC, IVDD 98/79/EC, Animal tissue directive 2003/32/EC, Blood directive 2000/70/EC
Full scope for all directives full scope
Canada     CMDCAS ISO 13485
USA          FDA third party review 510(k) program, FDA trial audits
Taiwan:     Recognition formally only for EU, Swiss companies are also eligible for the Taiwanese TCP program
Australia: Recognition (formally only for EU)
Japan:   Accreditation under the Japanese Pharmaceutical Affairs law
China:    No role for Third Party. Consulting organization in Beijing that assists medical device manufacturers with approvals for China (SFDA, CQC)
- Quality system certification services: ISO 13485:2003 , ISO 9001:2008 and ISO 14001
- One global team of experts, operating in 29 European countries as well as in North America, Brazil, South Africa and China. Offices in The Netherlands, Germany, Denmark, Switzerland, Israel, Japan and the USA
- Special Expertise / references: Cardiovascular surgery, Minimal invasive surgery, Active implantables, Intravascular catheters, Drug/device combinations, IVD, Animal tissue, High-tech start-up companies, Ophthalmic surgery, Wound care products (drug/device combinations), Body contouring implants
- One contact person within the Business Line (short communication lines)
- Additional guidance, pre-certification services and training.
- References:

Neurostimulation Cyberonics, American Medical Systems
Ophthalmic surgery Advanced Medical Optics, Staar Surgical, Ophtec
Diagnostic and therapeutic electro-medical devices Nucletron, Philips Medical Systems, Siemens Medical Systems, Dräger Medical, GE Healthcare, Gyrus – AMCI
Cardiovascular surgery Boston Scientific Corp, Abbott (Guidant Endovascular), Edwards LifeSciences, Vascular Solutions, Clearstream Technologies, Cierra, Biotronik, Asahi
Cardiac rhythm management Medtronic
General surgery, vascular intervention C.R. Bard, Kimberly Clark, Medcomp
Other clinical areas Bayer – Schering, Q-Med, Numico, B.Braun, Johnson & Johnson
Specialized projects – start-ups Many start-ups, Ventricular assist device, Minimal invasive placement of heart valves
In Vitro Diagnostics Becton Dickinson, General Biologicals Corporation, LifeScan Inc., Deutscher Blutspende Dienst, Nanogen Adv. Diagn. S.r.L., Omega Teknika
DEKRA Certification B.V. would like to get into contact with RA Managers, QA Managers and Project Managers who are active within the manufacturing, the design and/or the development of Innovative Medical Devices, Active Implantable Devices and/or In-Vitro Diagnostic Devices, especially start-up companies.