Quality-Audit offers medical device consulting to help companies achieve and maintain compliance to regulations and standards by providing indepent assessment and services.
The Medical Device industry is regulated by ever-increasing compliance and regulatory requirements. The increasing demands are intended to strengthen patient safety and to ensure adequate accessibility of medical devices. The goal is better patient safety in all respects.
The safety of patients will be improved, among other things, by tightening the rules in accordance with requirements regarding how new medical devices are placed on the market. Also, monitoring of products already on the market will be increased. However, the change in compliance level, and sometimes in compliance culture, is not easy.
Areas of expertise
Quality-Audit offers medical device consulting on the following compliance related tasks:
- ISO 13485:2016
- Medical Device Regulation (EU) 2017/745
- FDA 21 CFR 820
- Risk Management in accordance with ISO 14971:2019 (and 2012)
- Validation/Qualification of processes and software
- GAP Assessments