Yes daily. We are very proud that CertHub has numerous successful partnerships and customers ranging from large medium sized companies to startups who used our systems successfully in Audits and are enjoying how streamlined their regulatory processes are using the platform.

Yes, CertHub’s expert Auditor team offers assistance with audit preparation and execution, ensuring you meet all necessary requirements. We are in close exchange with several notified bodies.

CertHub is tailored to the needs of Small-and-Medium Sized companies, Scale-Ups and StartUps (Our speciality is: IVD, SaMD and hardware medical devices). It is the right fit for companies who want more than a quick-and-dirty high maintenance solution - A future-proof affordable technology companion which growths with the growing needs of the company (e.g. full-adaptability, customisability, continuous compliance, AI Use Cases, etc.). The people who are using CertHub are Quality Managers, Regulatory Affairs Specialists, Founders, Technical Engineers, Managing Directors, Department Heads, and Consultants working in the medical device industry.

Depending on the complexity of your project, CertHub can help you create compliant documentation ranging from few days to few months instead of years.

By automating document creation and regulatory tasks, CertHub helps companies reduce the time to market by years and significantly lowers costs associated with compliance and quality processes. For some of our customers the time and cost savings were up to 60%, comparing the overall costs for compliance and quality with our fair prices we offer an outstanding value for money and Return of Investment. Not even considering the revenue business potential of market approvals in several Jurisdictions (Europe, USA, Brasil, etc.) TL;DR The costs of non-quality are always higher and high quality is THE business advantage in MedTech

CertHub provides intuitive workflows, pre-built templates, and guided steps to Get-Started easy as well as a great network of regulatory experts for all disciplines. Depending on the complexity of your medical device often customers also grow their own competences on the fly or get additional external support.

The majority of our customers are using the following frameworks for MedTech compliance: *MDR* (Medical Device Regulation – EU 2017/745) and *IVDR* (In Vitro Diagnostic Regulation – EU 2017/746) USA: *Premarket Notification 510(k) Path +* US FDA 21 CFR Including the latest standards to streamline your compliance process (e.g. ISO 13485, ISO 14971, IEC 62304, and IEC 62366) In addition, thanks to our very modular and adaptive system, our customers are very successfully using our system daily also for related standards such as ISO 9001, ISO 14001, ISO 50001 and regulatory frameworks such as EU AI Act for a real All-in-One Product Compliance solution covering your integrated Quality Management Systems and Documentation records.

Yes, what makes our system unique and future proof is that the CertHub can be tailored to your companies specific needs and offers adaptable workflows and templates, very much different to some “hard-coded” systems out limiting the users to pre-defined configurations.

Yes, you can export your data anytime with a single click, ensuring flexibility and control over your documentation

CertHub prioritizes data protection and security in everything we do. Your data is handled confidentially, stored securely, and can be exported at any time. Reach out to us, we have an information package regarding Data Protection & IT Security ready for you.

You can export your data when canceling your subscription in a easy systematic and machine-reading way, our philosophy is we want to keep you happy on the entire journey from On-Boarding to Off-Boarding, no exceptions.