Wanda Sordoń, PhD

Regulatory Affairs Specialist

Regulatory Affairs Specialist, PhD in Analytical Chemistry and Electrotechnical Techniques and MSc in Biomedical Engineering with broad experience in medical device compliance, especially technical documentation in accordance with MDR 2017/745.

Author's articles

20 min read

Everything you need to know about ISO 13485 software development

ISO 13485 (medical devices)

5 min read

6 tips for successful MDR compliance

5 min read

Most common mistakes leading to MDR certification delays

4 min read

Who is a critical supplier in the context of ISO 13485?

ISO 13485 (medical devices)

A picture showing a hand holding smathphone.

13 min read

IEC 62366 in medical software – a guide for manufacturers

10 min read

9 things you should know about the AI Act in healthcare

3 min read

How DigiG influences DiGA?

15 min read

Medical software certification – a guide for managers

11 min read

What is DTx - from idea to certification

6 min read

Medical Device Regulation (MDR) and its consequences for healthcare software development

15 min read

Medical software certification – a guide for managers

18 min read

Wanda Sordoń, PhD

Author's articles

Everything you need to know about ISO 13485 software development

6 tips for successful MDR compliance

Most common mistakes leading to MDR certification delays

Who is a critical supplier in the context of ISO 13485?

IEC 62366 in medical software – a guide for manufacturers

9 things you should know about the AI Act in healthcare

How DigiG influences DiGA?

Medical software certification – a guide for managers

What is DTx - from idea to certification

The most popular

Medical Device Regulation (MDR) and its consequences for healthcare software development

Medical software certification – a guide for managers

How to build a SaMD: a step-by-step guide