Quality Management System
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.
A bespoke QMS that is fully compliant to ISO 13485:2016, containing >50 procedures and associated forms can be installed, trained and fully operational within one month.
CE Technical File Development
For companies developing new medical devices and IVD's, gaining a CE mark can be a slow and confusing process. That is why we have developed the Technical File Template (TFT). The TFT is designed to simplify the entire process and to greatly reduce the time taken to get your product to market.
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!
The TFT will save you literally hundreds of hours of administrative work and help you structure your entire Technical File. By using our TFT you can ensure you meet all the requirements of CE Marking.
Head of Quality
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 (MDD 93/42/EEC)
- CE Marking for In Vitro Medical Devices (IVDD 98/79/EC)