Quality Management System
A bespoke QMS, compliant to ISO 13485:2016, containing >50 procedures and associated forms can be fully operational within one week.
By working with the client and understanding their needs, we can quickly create, install and train a QMS that works in harmony with their business and fulfils all the requirements of ISO 13485:2016.
CE Technical File Development
For companies developing new medical devices (MD, IVD's & Software), gaining Regulatory Approval can be a slow and confusing process. That is why we have developed the Technical File Template (TFT). The TFT can save you hundreds of hours of administrative work and will help you structure your entire Technical File. By using our TFT you can ensure you meet all the requirements necessary for Regulatory Approval.
A TFT, containing more than 70 completed documents that are numbered, structured and bespoke to your company and the new product can be provided within one week!
Head of Quality and 'Management Representative'
Training, Coaching, Mentoring
- Understanding ISO 13485:2016
- Understanding the CE Marking process for Medical Devices
- Understanding the CE Marking process for In Vitro Medical Devices
Gap Analysis & Due Diligence
- ISO 13485:2016
- CE Marking for Medical Devices (MDR (EU) 2017/745)
- CE Marking for In Vitro Medical Devices (IVDD 98/79/EC & IVDR (EU) 2017/746)