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CONSULTING - Healthcare

Request For Quote ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices Why do you need this?

ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.


- Increase access to more markets worldwide with certification
- Meet regulatory requirements and customer expectations
- Increase efficiency, cut costs and monitor supply chain performance
- Demonstrate that you produce safer and more effective medical devices

How Avanta can assist

- Development of manual, procedures and other relevant documents.
- Identifying hazards and hazardous conditions associated with a medical device that could place patients or healthcare workers at risk.
-  Estimating the potential occurrence of such risks, and evaluating the extent of the consequences.

Contact Us

Email: enquiry@avanta.com.sg
Tel: +65 6417 1151
Fax: +65 6295 6683
Address: 72 Bendemeer Road, #03-29 Luzerne, Singapore 339941