Are you subject to strict regulatory and normative requirements?Â
đź’‰ ISO 13485:2016 - MDR (EU) 2017/745 - 21 CFR part 820
âś… ISO 9001:2015
♻️ ISO 14001:2015 - ISO 14021:2016
QARAKAHL provide its expertise, combining compliance and performance, to serve you.
Implement a compliant quality system.
Optimize processes.
Conduct internal and supplier audits.Â
Contribute to the development of technical documentation and support the registration of CE-marked medical devices.Â
Implement regulatory and normative monitoring.
Assist in the definition of a risk-based regulatory strategy.Â
Conduct a diagnostic of your organization's readiness for change acceptance.
Capture external knowledge and internalize it.
Steer systemic projects.
Desire to change?
First, we'll need to understand why you want to make a change.