Medical Device News Magazine

Friday, March 24, 2023

MedSafety Solutions Earns EU-MDR Certification

Meets New, Strengthened Requirements for Safety and Performance

MedSafety Solutions today announced that it has received the European Union Medical Devices Regulations (EU-MDR) certification as of September 9, 2021.

This achievement is a major milestone for MedSafety Solutions in its ongoing mission to provide hospital pharmacies in the European market with the products and expertise they need to perform safely and effectively.

The British Standards Institution BSI completed their conformity assessment to include quality management systems as well as general safety and performance standards. As a result of this assessment, conducted by audit and technical review, BSI determined that MedSafety Solutions met the needed requirements and issued its EU Quality Management System Certificate.

“Receiving this certification demonstrates our commitment to compliance with new regulations and to meeting customers’ needs safely and predictably,” says Steve van Engen, founder and CEO at MedSafety Solutions. “Additionally, receiving this certification ahead of many other companies will serve as a distinct competitive advantage.”

This news takes on significant importance in that the new certification:

  • Is significantly more stringent than the Medical Devices Directive (MDD), the previous regulatory framework
  • Comes as a result of strict performance assessments of MedSafety Solution’s quality management systems and an evaluation of general safety and performance indicators
  • Enables MedSafety Solutions to advance its position in the European market

To learn more about the EU-MDR certification, click here to contact us.

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