Our QARA team brings deep expertise in international regulatory frameworks to support your medical device approvals under MDR and other global requirements. We work closely with our clients to streamline the path to market, reduce time-to-approval, and ensure full compliance throughout the product lifecycle.
We can be the legal manufacturer for your device or we can support you in your MDR registration and supply you with all the needed technical documentation.
Our Regulatory & Quality Services include:
- Regulatory strategy development tailored to your product and target markets
- 510(k) submissions for the U.S. FDA
- CE Mark technical documentation under MDR
- Authorized Representative services (EU / UK / Switzerland)
- Clinical Evaluation Reports (CERs)
- Biological Evaluation Reports (BERs)
- Support for other international registrations (e.g. TGA, ANVISA, PMDA)
- V&V activities
We are also MDSAP certified, which gives you access to the Canadian market access.
In addition, we manage the validation of sterilization processes (EtO, Gamma, Beta) in full accordance with applicable ISO standards, supporting both validation and routine release phases.
