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:
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) âš• 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…
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: