You could guarantee a successful audit when you prepare your team before the real one.
The scope and methodology are determined with you and carried out by an expert professional. After performing the audit, an audit report is shared with your team in accordance with the relevant standards and regulations.
We provide audit services in accordance with the following standards and regulations;
- Medical Device Directive (93/42) amended by 2007/47/EC
- Medical Device Regulations (2017/745)
- EN ISO 13485:2016
- EN ISO 9001:2015
Repeating the audit due to non-compliances causes time, morale and financial loss. Having a GAP audit eliminates the risk of having non-compliances. Thanks to our professional consultants who have the experience and knowledge in the field, we assist you comply with the relevant regulations in full.
To see your compliance situation according to EN ISO 13485:2016, Medical Device Regulation (2017/745) and work on a listed non-conforming issue we are ready to plan a GAP Audit.
Outsourcing some parts of your medical device is a common method to decrease the production cost. However, this method brings that you should also carry your suppliers’ risk.
With the new regulations, you are strongly forced to control your suppliers and make sure their products keep the quality standards that you identified in the beginning.
We audit your critical suppliers on your behalf according to the current and applicable medical device directive and other relevant standards.