Summary: DentalMonitoring received Medical Device Single Audit Program (MDSAP) certification from BSI for its AI-powered orthodontic monitoring software.

Key Takeaways:

  • The MDSAP certification encompasses and replaces the company’s previous ISO 13485 accreditation and, according to the company, streamlines regulatory audits across multiple global markets, including the United States, Canada, Japan, Australia, and Brazil.
  • This milestone follows FDA and MDR approvals last year, and is part of the company’s international development strategy.

DentalMonitoring has received a company certification under the Medical Device Single Audit Program (MDSAP) from BSI. The British Standards Institution, or BSI, is one of the oldest certification bodies worldwide. According to a press release from DentalMonitoring, this certification encompasses and replaces the International Organization for Standardization Medical Device Quality Management System (ISO 13485) that the company first obtained in 2019.

MDSAP certification attests to comprehensive regulatory audit requirements and compliance standards for medical device manufacturers operating in the United States (FDA), Canada (HC), Japan (MHLW), Australia (TGA), and Brazil (ANVISA).  The program streamlines audits and inspections by consolidating the process for multiple countries. This certification reportedly demonstrates the company’s commitment to quality standards and reinforces its reputation for safety and effectiveness.

This MDSAP certification for DentalMonitoring follows product FDA approval in the United States and product MDR certification in Europe for its AI-powered orthodontic monitoring software. The company stated the press release that these accomplishments underscore the ambition and dedication of DentalMonitoring to being a key and reliable partner for all the stakeholders in the orthodontic field.

READ MORE: DentalMonitoring Software Update Brings SmartSTL Feature

“Receiving certification from these prestigious organizations demonstrates DentalMonitoring commitment to regulatory and quality standards and it represents an important milestone in our global international development strategy,” said Arnaud Berthier, vice president of market access.

“Our clients expect DentalMonitoring to comply with the highest quality standards. We are proud to consistently exceed their expectations. This new certification addresses all processes using the applicable AI-based regulatory requirements approved by multiple governments including those in the USA and European countries,” said Thomas Pellissard, DentalMonitoring COO and co-founder.

“Achieving these regulatory and quality standards is crucial for our company’s success as we continue to invest in our global growth and internationalization,” said Philippe Salah, DentalMonitoring CEO and co-founder.

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