Stay informed with the latest regulatory news, industry updates, and expert-led podcasts covering medical devices, digital health, and compliance developments.
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 […]
In this session, Will Sanders of Greenlight Guru interviews Adnan Ashfaq of Simplimedica to discuss:
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.
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, […]
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 […]
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. […]
UK Medical Device Regulator MHRA Announces Legislative Updates After the new legislation was laid out on 21 October 2024, a six-month transition period is provided, whereafter the amended regulations will come into force on June 16, 2025. This period allows stakeholders to adapt their processes and ensure compliance with the new requirements. In January 2025, […]
UK Medical Device Regulator MHRA Announces Legislative Updates The Post-market Surveillance (PMS) Statutory Instrument (SI) laid in Parliament on 21 October 2024 was the first major update to the framework of medical device regulations in Great Britain. Since January 2021 all medical devices have been required to be registered with the MHRA before they can […]
UK Medical Device Regulator MHRA Announces Legislative Updates The MHRA, the UK medical device regulator, gave a progress report on the agency’s work toward completing its roadmap of medical device legislation. On September 18, Robert Reid, Ph.D. Deputy Director, Innovative Devices at the MHRA, updated the RAPS audience on the current status of the UK […]
MHRA announces a proposed framework for international recognition of medical devices The Medicines and Healthcare products Regulatory Agency (MHRA) on 21 May 2024 published a statement of policy intent for international recognition of medical devices. The MHRA’s statement of policy intent describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the […]
Update from MHRA on UK MedTech Regulatory Reform The UK medical device regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), presented a webinar (March 5) on the upcoming changes to the medical devices legislation for Great Britain (GB). The webinar provided an update on the draft policy on scope, classification and essential requirements for […]
MHRA sets out a new Roadmap to protect patient safety and allow access to medical technology including AI and diagnostics. Medicines and Healthcare Products Regulatory Agency (MHRA) has published a roadmap for developing new and robust regulations for medical devices in the UK and are designed to provide greater international harmonisation. Access roadmap for 2024/2025 […]