Quality Management Systems

We can provide you with procedures and forms that meet global requirements for sourcing, design, manufacturing, and distribution of medical devices. 

Complete compliance applies to:

• FDA 21 CFR Part 820
• ISO13485:2016
• Europe MDR  Regulation (EU) 2017/745 
• MDSAP
• Health Canada  Medical Devices Regulations (SOR/98-282) 

The procedures are provided in word and can be easily customized to the risk and complexity of your business. Request today a list of available procedures and forms.

We can also provide you with simple Tracking Tools for your different Quality Programs, including:

• Licensing and Registrations
• CAPA
• Complaint Files
• Training
• Calibration and Maintenance
• Etc.

Avoid spending thousands of dollars on consulting services to write procedures for you.