Unser Solutions

Our Services

Pre-Market

  • Develop and implement Regulatory Strategy
  • Setup, implement and maintain Good Distribution Practice
  • Prepare and submit for Product Registration

Post-Market

  • Develop and implement Regulatory Compliance System
  • Setup, implement and maintain Post-Market Surveillance System

Training

Strengthen competency of your staff with regulatory training. Our training are available to the public or as in-house training.

Goods Distribution Practice for Medical Devices

The Good Distribution Practice for Medical Devices (GDPMDS) is a mandatory certification for any organizations involved with importing, wholesale and distribution of medical devices prior to their license application.

  • Learn the basic of GDPMDS requirements
  • How to setup and implement a compliant system
  • Process of getting certified and maintaining the certification

Understanding the Regulatory Framework for Medical Devices in Singapore

1-day workshop that provides an overview to the different regulatory requirements for medical device regulation in Singapore.

A good introductory course for non-regulatory affairs professionals.

Certificate in Regulatory Framework for Medical Devices in Singapore

4-days workshop that covers the regulatory requirements for medical device regulation in Singapore.

This course will discuss the regulatory control model from GHTF/ AHWP/WHO/AMDD using Singapore’s regulatory framework. The course will cover practical aspects of risk classification, Grouping, CSDT, Essential Principles, Adverse event reporting and FSCA. Participants will understand the regulatory requirement for Singapore based on understanding of the law (Act and Regulations).

Past Events

The Upcoming EU Medical Device Regulations - What Regulatory Professionals Should Know

Half day seminar with Dr Arthur Brandwood from Australia to share on the upcoming Medical Device Regulations in Europe. Awesome sharing to a full house by Arthur.

Want to be updated on our next event. Send us your contact and we will keep you on our mailing list.

[see event]

Co-Organised with

MDnet.Regulatory Consultants

Who you will working with

SEET Wing Gang, RAC

Wing Gang has been in the medical device industry for the over 15 years. Working in Quality Management and Regulatory Affairs in manufacturing plants as well as regional offices. Wing Gang had served in the Health Sciences Authority of Singapore for 6 years, the last appointment held was Deputy Director of Evaluation Unit, Medical Device Branch. He was part of the team that developed and implement Singapore’s regulatory framework for medical devices.

Wing Gang works with medical device companies in the APAC region with product registration, quality system and regulatory compliance.

Wing Gang also conduct training on regulatory compliance for medical devices. He have spoken and conduct training in regional conferences and countries including Thailand, Vietnam, Philippines and Indonesia.

Wing Gang has a diploma in Biotechnology (Ngee Ann Polytechnic), Honours Degree in Chemistry (National University of Singapore) and Masters in Technological Design (Joint Degree by Eindhoven University of Technology and National University of Singapore).

Contact Us