Compliance
Our Commitment to Quality
At INOVIQ, quality means much more than just compliance, as we strive to ensure:
- Our technologies and solutions are of the highest standard
- Our research, development, and manufacturing are of the highest quality
- Our people are of the highest calibre
- Our partners are world class
| ISO 134485 |
Our Quality Management System (QMS) is certified to ISO13485:2016, the internationally recognised standard specific to the medical device industry. |
| FDA |
As an FDA Registered Facility, our systems and processes also comply with the FDA Quality System Regulations 21CFR Part 820. |
| GMP |
Our on-site manufacturing operates under strict Good Manufacturing Practices (GMP), ensuring product quality and integrity. |
| CE Mark |
Our CE Mark approval allows commercialised product to be marketed in the European Union and indicates conformity with all the requirements of EU performance and safety standards. Compliance is verified by BSi, the leading EU Notified Body. |
| EU Authorised Representative |
Supporting our European presence, we have partnered with MDSS, based in Hannover, as our EU Authorised Representative, ensuring we remain at the forefront of European Regulatory Requirements. |
