Medicolegal Profile

Background

  • Mawaddi is a clinical evaluation specialist or clinical reviewer at TUV SUD, with background of clinical, research and occupational audiology. He is fiercely skilled in clinical evaluation, clinical research, Post-Market Clinical Follow-Up, Post Market Surveillance, risk management, audiological assessment and audiology medical devices. Mawaddi graduated from International Islamic University Malaysia (IIUM), undergrad with Bachelor of Audiology (Honours), and postgraduate in Master of Medical Sciences (Audiological Sciences). Before involved in clinical evaluation and review journey, he also work in clinical settings at private hospital and audiology sales, research assistant at government agencies institute, and sale & services based at private hearing aids company.
  • To carve his path in evaluation specialist, Mawaddi are trained and certified by numerous bodies. Among them is training for Risk Management for Medical Devices and ISO 14971:2019 by Medical Device HQ, Understanding of FDA 21 CFR Part 820 Quality System Regulation by BSI and Clinical Evaluation for Market Approval by World Medical Device Organization.
  • As medicolegal portfolio of MANSA, he aims for his portfolio to achieve innovative conformity; finding innovative solutions and approaches to address medicolegal challenges in audiology, while still adhering to the established norms, regulations, and best practices in Malaysia

Designation

  • Medicolegal Portfolio Exco of MANSA

Role of Portfolios

  • Promote, support and represent members on medico-legal knowledge and issues.
  • Liaise with other societies or organizations in medico-legal matters that may have medico-legal implications for the advancement of medico-legal knowledge. I
  • Facilitate in reviewing and revising current regulations and policies to maintain relevance to current practice with key stakeholders

Standpoint and Focus in Audiology

  • Occupational audiology, clinical development of medical device, clinical research
  • Audiology field has a very good potential to be expanded not only clinical but into research & development, and also expansion in terms of scope of practice.