ISO 13485 (Certificate PDF). Innodem Neurosciences has obtained MDSAP (Medical Device Single Audit Program) certification to ISO 13485:2016. This certification attests that we meet the requirements for design and implementation of a quality management system (QMS) as specified in the Standard and demonstrates our ability to provide medical devices and related services that consistently meet customer expectations and applicable regulatory requirements.
Ethics and Regulatory Compliance
Innodem Neurosciences is committed to the respect of the privacy of its users and partners through compliance with applicable laws, regulations and ethical standards in each of the markets in which it operates. All employees are required to adhere to these laws, regulations and ethical standards, and management is responsible for ensuring such compliance.
To underline the importance of this commitment, we have formulated our position on legal requirements and ethical issues in our Security and Data Privacy Framework, which serves as a guide to our behavior in business dealings.
This Framework explains how our operations and systems are designed for compliance with regulations such as HIPAA, PIPEDA and others. We intend to extend our compliance with additional regulations as we extend our activities.
For any questions regarding our respect of these regulations you can send an email to firstname.lastname@example.org.