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NORMALISATION

Standards are part of our day to day environment

In the medical device and IVD sector standards help to increase patient safety, give better protection to medical staff, are used in tenders, are integrated in reimbursement processes, open new markets, and so much more. As a regulatory professional you are meant to be aware of new standards and their implications for the manufacturer and other stakeholders.

Standards ensure that medical devices are state of the art and are an essential tool for any company to prove compliance to European directives and facilitate conformity assessment (CE Marking). Companies that are involved in standards development will have less issues with compliance.

Benefits of participating in standardisation :

  • Easy compliance with European law
  • Business performance improvement
  • Increased competitive advantage
  • Cost reduction
  • Networking
  • Professionalization of the sector
  • Facilitation of a specific business
  • Learning curve

Medical Device companies who can pre-empt standards changes and developments will optimize resources and project an innovative market approach.

Being informed of upcoming standards gives you a head start

Since 2008, beMedTech was granted the privilege of serving as the sectoral operator for NBN (Belgian Standards Institute) for the Medical Device and In-Vitro Diagnostic Device sector and is reponsible for coordinating the standardisation work in Belgium. beMedTech Standards finds itself with this close link in a unique position, based on its experience as a medical device, trade association, to inform its standardisation members of any changes to standards and thus to facilitate active participation from Medical Device and In-Vitro Diagnostic Device stakeholders in the standards development process.

How does beMedTech Standards benefit your company ?

Having a direct communication link with NBN, ISO and CEN, beMedTech Standards is ideally placed to serve your needs of staying informed of, influencing and actively participating in the standardisation development process.

beMedTech Standards informs its members in a timely manner of the goings-on of standards that (in)directly affect you and pre-empts any implications this may have for your product/company. beMedTech standards offers a comprehensive service with a direct link to all standardisation documents relevant to your products through one central email and facilitates the voting by your Belgian affiliate.

Click here for a complete list of the technical committees in CEN and ISO nominated by beMedTech.

Interested in joining beMedTech standards? Complete the questionnaire and send it back to us

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