October 10, 2023

What are some pitfalls to avoid during Software Design?

35 minutes

More and more companies are starting to develop Software as Medical Devices (SAMD) and in this podcast episode, I have invited Weronika Michaluk to talk to us about some pitfalls that you need to avoid.

Weronika will talk about:

- Risk Management

- Usability

- Documentation

- Expertise

- Interoperability and scalability

- Cybersecurity.

So don’t miss that and don’t hesitate to contact Easy Medical Device if you have some questions.

Who is Weronika Michaluk?

Weronika Michaluk is an experienced professional with a diverse background in the fields of biomedical engineering, international business, and public health. She is a Biomedical Engineer by training, holds a Master's degree in International Business from the University of Miami, an MBA from the Warsaw School of Management, and a Doctorate in Public Health (DPH) with a specific focus on the business strategy of Agile Development of Software as a Medical Device (SaMD).  Weronika's career began as a Biomedical Engineer, where she contributed to the development of various biomedical devices, including a wireless ECG system, then she worked in South Korea in the Neuroscience Department and after that she focused on digital health solutions and consulting in the medical device space.

Currently, Weronika serves as the Digital Health Principal and SaMD Lead at HTD. In this role, she leads the Software as a Medical Device department, utilizing her expertise in biomedical engineering and business acumen. Her primary objective is to ensure that all products are meticulously designed and developed, adhering to the highest quality standards. Weronika's dedication to customer satisfaction and patient safety is instrumental in driving the success of the organization and its customers. 

In her free time Weronika enjoys learning new languages (speaks 5 currently), travelling the world, playing sports, hiking ( she recently hiked Kilimanjaro, plans to hike to Mount Everest base camp next year) and discovering the unknown.

Who is Monir El Azzouzi?

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.

Link

Weronika Michaluk LinkedIn Page: https://www.linkedin.com/in/weronika-michaluk-mba-43811698/

HTD Health website: https://htdhealth.com/

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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