Creating a Regulatory Roadmap for MedTech Market Success with Etienne Nichols

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Adnan Ashfaq of Simplimedica, a seasoned quality, regulatory, and validation specialist, to explore the critical role of developing a regulatory roadmap for medical device companies. Adnan breaks down the differences between a regulatory strategy and a regulatory roadmap, highlighting how a…

Medical Device Consultant service for your support

In this podcast, Adnan Ashfaq (Simplimedica) met with Monir El Azzouzi (Easy Medical Device) at Medica 2023 in Dusseldorf, Germany to discuss the current challenges regarding medical device regulation.

Assessing the Global Regulatory Landscape

With medical device regulations tightening worldwide, especially in Europe, it’s important to assess the changes unfolding across the global regulatory landscape to fully understand how it impacts your business and product. In this episode of the Global Medical Device Podcast Jon Speer talks to Adnan Ashfaq, founder of Simplimedica, about the changing global regulatory landscape,…

Understand IEC 62304 for Software Medical Devices

If you are developing Medical Device software then IEC 62304 is an important standard for you. In this episode, Monir El Azzouzi invited Adnan Ashfaq from Simplimedica to explain to us what is this standard. He will also mention some key links to the EU MDR 2017/745 and to other standards. Here are some of…

How to perform Process Validation for medical devices? (IQ OQ PQ)

Process Validation is a science but it needs also some education. In this episode of the Medical Device Made Easy Podcast, we will help you understand what is Process Validation. If you are a Medical Device Manufacturer or if you are an engineer who wants to understand Process Validation, then this episode is for you….