While many companies claim to offer compliant digital health solutions, few have the certifications and experience to back it up.
Here at BrightInsight, we've had our ISO 13485:2016, Medical Device Single Audit Program (MDSAP), and Hébergeur de Données de Santé (HDS) certifications, among others, for several years. And what’s more, we’ve actually built 18 complex Software as a Medical Device (SaMD) solutions and companion apps, and undergone 46 regulatory audits for a number of products built under our Quality Management System (QMS). Our multi-year renewals of these key certifications serve to illustrate that BrightInsight is at the forefront of quality and regulatory excellence.
Keeping our certifications up to date is just one of many ways we support our biopharma and medtech partners. We take global standards seriously, and we're always on the leading edge when it comes to new compliance regulations.
BrightInsight’s compliance team is made up of true industry experts who can consult on strategies for reducing risk while delivering vital security, privacy and regulatory compliance. We stake our reputation on each of the 46 regulatory audits we’ve completed to date. We invest more than 500 hours to complete each audit to ensure it meets the highest expectations of the regulatory body.
Here's a brief overview of a few certifications we've recently renewed.
This certification demonstrates that we have a compliant QMS for software development services. As we work in the medical device sphere, this is a critical certification. The BrightInsight Platform was built with a compliant QMS, and in order to have this certification renewed, our processes and documentation were audited.
Our MDSAP certification demonstrates that our QMS meets additional requirements to facilitate a global approach to auditing and monitoring the manufacturing of medical devices, thereby improving oversight on an international scale. This enables us to speed time to market for our partners. Medical devices and SaMD hosted on our compliant platform get to end users more quickly, and our partners can rest assured that our QMS is compliant.
The HDS certification focuses on service providers that host confidential patient data. Our re-certification required us to submit a list of perimeters to ensure that personal health information (PHI) is stored, processed and backed up appropriately on the BrightInsight Platform.
In addition to the certifications we've recently renewed, we also hold the following certifications:
Want to learn more about our current certifications? We make it easy for our partners to get access to our documentation.