Regulatory and Medical Device Compliance - FAQs

Is Alakin a certified medical device?

Yes, Alakin Platform is classified as a CE Class I medical device under the MDR (EU Medical Device Regulation 2017/745) in Europe. It complies with regulatory requirements for safety, performance, and risk management.

Do I need to certify my care pathway under the MDR?

If your care pathway stays within Alakin’s intended use, no additional certification is required. However, if your care pathway performs medical functions beyond Alakin’s scope (e.g., automated clinical decision support, diagnosis, or treatment recommendations) and qualifies as Class IIa or higher, you must obtain independent MDR certification from a Notified Body.

Are you ISO 13485 certified?

No, we are not ISO 13485 certified yet; however, we prioritize quality and incorporate the standards into our processes.

How do you handle incidents and reportable events?

We have a Materiovigilance process in place to manage safety-related incidents. If you experience an issue, you can report it via our Quality Complaints and Materiovigilance Report Form or contact [e-mail]. Our team investigates all reports and, if necessary, escalates them to regulatory authorities.