Med-Tech MasterClass Part Five: Start Up Essentials
This webinar is essential for those starting in Medical Device Development for the first time and who know nothing about regulations. We will look at:
December 2024 – Medical Devices Regulatory Insights
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…
Med-Tech MasterClass Part Four: Medical Device Equipment Software Validation : A Balanced Approach
In this webinar, we will simplify the approach to validating software for QMS and Equipment to ISO 13485, Clauses 4.1.6 and 7.5.6.
Med-Tech MasterClass Part Three: Medical Device Packaging Validation Regulatory Essentials
This time we will be discussing Medical Device Packaging Validation: Regulatory Essentials. We will look at : 💉 Sterile Packaging Requirements (including testing) ⚕ Non Sterile Requirements 🔬 Statistical Sampling Requirements during validation 😷 Cleanroom Requirements We will discuss: How this fits into your Device Development for submission to Regulatory Authorities for FDA, MDR and…
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…
September 2024 – Medical Devices Regulatory Insights
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…
Free Webinar – Process Validations: an overview
Process Validation is a subject area that is not often discussed in webinars and an area left to engineers to figure out for themselves and to learn on the job. Still, there is some guidance and best practice in validation. Over the coming weeks and months we will be looking at: Adnan Ashfaq is a…
SaMD (Software as a Medical Device) for Ministry of Health Malaysia
This online session is to provide an understanding on Medical Device Software and how to comply with Regulatory Requirements. Through this session, the audience will be able to understand the role of medical device:
Intended Use Statements – The Beginning and End of the Regulatory Journey
In this session, Will Sanders of Greenlight Guru interviews Adnan Ashfaq of Simplimedica to discuss:
July 2024 – Medical Devices Regulatory Insights
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…