Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme US FDA 21 CFR Part 820 – Quality System Regulation INTRODUCTION The US FDA 21 CFR Part 820 – Quality System Regulation was developed and published to regulate and…
Medical Device Training in Malaysia – HRD Corp Claimable Course Labelling of Medical Devices (ISO 15223-1:2016) & Medical Device Classification INTRODUCTION Medical devices open the possibilities for a multitude of medical procedures from a non-invasive sprained elbow bandaging, in-vitro fertilisation to…
Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme Test Method Validation INTRODUCTION / OBJECTIVES Software Validation Requirements and Excel Spreadsheet Validation is a formalized, documented process for testing computer software and systems. The FDA and other regulatory…
Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme Test Method Validation INTRODUCTION The global medical device market is governed by various quality system requirements and regulations of different countries. Medical device manufacturers need to perform test method…
Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme ISO13485:2016 Internal Audit INTRODUCTION Internal audit is a mandatory requirement of ISO 13485 2016 as it mandates the review and evaluation of the organisation’s quality management system QMS to…
Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme ISO13485:2016 Quality Management Systems INTRODUCTION Medical device regulatory requirements are becoming more stringent throughout every step of a medical device life cycle, including service and delivery. Increasingly, organizations in…
Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme EU Medical Device Regulations (EU MDR 2017/745) OVERVIEW The EU Medical Device Regulation (MDR) 2017/745 was published on 5th May 2017, and it has replaced the EU Medical Device…
Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme Risk Management for Medical Devices (EN ISO 14971:2019) INTRODUCTION ISO 14971 is an ISO standard for the application of risk management to medical devices. ISO 14971:2019 was released mid-December,…
ARISE Plus Malaysia: Workshop on EU Regulation 2017/745 for Medical Devices (EU MDR) for Malaysian SMEs 21-23 September 2022 – Pullman Bangsar, Kuala Lumpur – The 3-day workshop on The EU Medical Device Regulation (MDR) 2017/745 was attended by 40 participants.…
ARISE Plus Malaysia: Workshop on EU Regulation 2017/745 for Medical Devices (EU MDR) for Malaysian SMEs Date: 15, 16 and 17 August 2023Time: 9.00am – 5.00pm (Registration starts at 8.30am)Venue: Pullman Kuala Lumpur Bangsar, 1, Jalan Pantai Baharu, Jaya Tower…