Are you looking for ISO 13485 Certification? We can meet your budget and get you certified in 60-90 days!



Compliancehelp is a consulting firm specializing in ISO 13485 Medical Devices Management Systems to assist organizations achieve ISO certification and compliance.


We develop a fully customized quality management system based upon what you actually do and that meets your expectations, budget and timeline.



We work closely with you so that you can retain all your existing good regulatory requirements and quality management practices and even help you improve. Let us change your perception of ISO certification. All of our customers have been surprised at how simple the process is for certification.


We are committed to meeting your timeline. Most clients are certified within 3 months, some within 30 days! Think what you could be potentially missing out on if it took too long to get certified. Our unique method is lean and fits right in with your existing processes. No Shortcuts, and as proof, almost all of our clients achieve certification without any corrective actions.


Our unique lean methodology means we don’t need to spend a long time at your premises and you don’t need to spend an age preparing for certification. We have it down to a fine art! So not only do you spend less for a great consultant, but you spend less of your own time and money preparing. And we do all the documenting for you.

“Easiest and smoothest implementation of any accreditation that I have ever done. I would work with Compliancehelp on any certification in the future.”

Valentina Taparcevski – Qual. Co-Ord.