You can count on us during every stage of your medical device processes, from the beginning of a design cycle right through to manufacturing and post-market surveillance. Accelerate your quality management processes but also solve non-quality related challenges within your organization with our end-to-end and all-in-one life sciences platform by your side.
Dodge document anarchy through centralized document control and easily export documentation packages for regulatory approval to rapidly obtain ISO 13485 Certification. Finally adopt a clear risk-based approach to medical device design and development, enhance quality management efficiency and, ultimately, get your medical device on the market faster.
The next challenge after obtaining ISO 13485 Certification for your medical device is to retain it (effectively). Our platform is designed with medical devices in mind, and supports you in impeccable risk-based design and document management. Simply connect and export the documents you need in a couple of clicks.
Validating is costly and time-intensive. We offer fully validated quality management modules that saves that headache! Our software is pre-validated according to GAMP5 and 21 CFR part 11. Pick and choose the modules you need to build up a completely custom and fully cloud-based compliant system. Our software is frequently updated, so you can keep up with the most up-to-date regulations.
We help you ensure inspection-readiness by safeguarding your product and quality management processes, critical in such a highly regulated industry. Risk assessment is infused into our platform, so you can rest assured knowing you’ll have a spotless audit trail at any time. From risk-proof design, to effective implementation of CAPAs, to compliant e-signatures and approval workflows, to painless assignment and follow-up of compliance trainings. Everything is transparent and traceable, all the time.
Join these innovative Medical Devices' organizations in transforming lives through science
Olfactomics Customer Story
Effortless ISO 13485 certification and processes
Improved Operational and Management Efficiency
Improved Employee's Trainings