Symbioteq provides trainings in regulatory affairs and quality assurance for people in the medical device industry. All our trainings are organized in cooperation with our partner, Key2Compliance, who also offers corresponding training for the pharmaceutical industry; read more about their training program here: www.key2compliance.com
Examples of areas in which we offer in-house trainings:
- MDR/IVDR – EU Regulations for medical devices.
- Medical Device Regulations in other countries (US/CAN/JPN etc)
- Product development and CE-marking of medical devices.
- Quality Management System according to ISO 13485:2016 and ISO 9001:2015
- Biocompatibility – Biological evaluation of medical devices – ISO 10993
- Development of medical device software – ISO 62304
- Application of risk management to medical devices – ISO 14971
- Environmental Management System – ISO14001:2015
For further information, please contact us at firstname.lastname@example.org and we will ensure you get an education that matches your needs.