WMDE

"Experience you can Trust"

European Authorized Representative

WMDE B.V. is a respected, world-class regulatory affairs firm and European Authorized Representative Medical Devices dedicated to providing regulatory services for medical device manufacturers around the world. We ensure that your products meet all regulatory requirements before, during and after launch. We understand the medical device industry and have experience to guide your products through regulatory requirements efficiently, cost effective and reliable.

  • 30+ years expertise: 

We have over 35 years of experience in Authorized European Representation and regulatory affairs services.

  • Companies we serve:

Midsize, small and emerging medical device companies. We have done work for leading medical companies, i.e. Medtronic Inc., (www.medtronic com), Pfizer (www.pfizer.com), etc. US, Canadian, European, Asian and Australian based companies.

  • Europe, USA, Japan:

Offices and partners in Europe, USA and Japan.

  • Global access:

Registration

We offer worldwide regulatory services i.e.:

Europe, U.S.A., Brazil, 

Japan, South-Korea, Australia, 

India, China, Russia.

  • English:

Documentation and communication are all executed in English. All staff is fluent in English.

  • Specialization:

We are specialized in regulatory services for medical devices and in vitro diagnostics companies.

  • All classes:

We handle the medical device approval process of all classes of medical devices, IVD, active implantables and combination products.

  • Italian medical devices database

Database and Repertorio – Medical Device Registration in Italy.

We have access to the Italian database for medical devices and have registered many devices. 

The registration in the Database and Repertory of Medical Devices (RDM) is mandatory in order to supply medical devices and equipment to hospitals in Italy. The Ministry of Health Decree (DM) issued on December 21, 2009, states that without this mandatory registration medical and surgical devices cannot be supplied to Italian hospitals. The database of medical devices collects information related to all medical devices released in the Italian territory by domestic manufacturers. Please contact us for further information. Contact us for Italian database services

  • Long term partner:

WMDE has long term partnerships with the companies we represent.

  • Complete services:

CE-marking medical devices, FDA, Sterilization advice, European representation, Regulatory affairs, CRO services, Quality Audits, registration, consult medical, medical device consulting firm, mdd, medical devices, medical device reulation, medical register, eto sterilization, steam sterilization, medical sterilization, sterilization validation, ce-certification, European directive.

WMDE B.V. services as European Authorized Representative Medical Devices

  • Product Notifications
  • Name and address of WMDE on labels and instructions for use
  • Language requirements for labels and instructions for use
  • Technical File Review for compliance with EU legislation
  • Technical File storage at WMDE office
  • Ec rep
  • Medical devices
  • Certificate of conformity
  • Ce mark medical device
  • Ce marking directive
  • Ce marking requirements
  • Medical device regulations
  • Medical device news
  • Medical device classification
  • Ivd directive
  • Ce europe
  • Medical device market
  • Iso medical device
  • Mdd eu
  • European authorized representative medical devices
  • How to get ce certification
  • Ce regulations
  • Europen medcal device directive
  • Mdd medical device directive
  • Notified body medical devices
  • Communication with European Competent Authorities
  • Notifications of serious incidents and recalls to authorities
  • Clinical Investigations Notification
  • Brexit regulatory strategy

Portfolio WMDE B.V.

  • Cardiovascular
  • Pulmonary
  • In Vitro Diagnostics
  • Dental
  • Imaging
  • Gastro intestinal
  • Wound care
  • Ostomy care
  • Software
  • Animal tissue
  • Sterilization control
  • Bio-absorbable surgical products
  • Home health care
  • Cosmetics
  • Radiology

When choosing WMDE B.V. you can rely on the following values:

  • Product and market expertise - Our experienced team has in depth knowledge of many medical device technologies and markets.
  • Reliability - Integrity and Predictability are core values for all team members
  • Partnership - Our goal is to establish a long lasting partnership with our clients so we can work together to meet their goals.
  • Result focused - We focus on goals and results.
  • Cost effectiveness - We do our work as cost effectively as possible.

Why do you need an Authorized European Representative Medial Devices?

In order to legally sell your medical products in Europe you need to be compliant with the medical devices legislation. If a company does not have a physical office in the European Union, a European authorized representative with a physical office in the European Union needs to be appointed.

WMDE B.V. will represent your firm as official European Authorized Representative in accordance with the applicable medical device legislation: MDD (93/42/EEC), AIMD (90/385/EEC) or IVD (98/79/EC).

Only one European Authorized Representative office (WMDE) is needed for the whole European Union. WMDE B.V. will represent you in 27 EU countries and Norway, Iceland, Liechtenstein and Switzerland.

 

 

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If you have any questions, please contact us by e-mail or telephone: +31 (0)475 58 22 85

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