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Reimbursement / Regulatory

AccelSPINE Receives CE Marking and EN ISO 13485 -

AccelSPINE received its CE Marking and European ISO 13485 certification, allowing the company to expand its customer base to the 28 countries that make up the EU and five additional countries that adhere to EU regulations.

The designations, effective November 18, 2015, were awarded to AccelSPINE by TUV Rheinland LGA Products GmbH after extensive quality assurance audits. The company’s ISO designations are EN ISO 13485:2012 and EN ISO 13485:2012/AC: 2012.

This achievement signifies a full quality assurance system for the company’s medical devices pursuant to Directive 93/42/EEC Annex II (excluding section 4).

Source: AccelSPINE

The European Commission and Notified Bodies are preparing to implement new, tougher European Medical Device Regulations in 2016. Read more about the proposed changes here.

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