IEC60601 / IEC62304 / IEC 62366

Together with our partners from Taiwan, we provide consulting services for :

IEC 62304  – Medical Device Software – Software Life Cycle processes

IEC62366 – Usability 

IEC60601 – Safety and essential performance of medical electrical equipment

QMS Consulting Services

We provide guidance to set up and implement Quality Management System (QMS) for our clients. The majority of our work revolves around ISO13485. We also provide guidance and advice to our clients regarding compliance to US FDA 21 CFR Part 820.  We have provided consulting services on GDPMDS for our clients in Singapore and working on GDPMD for our clients in Malaysia.

Regulatory Affairs Services

We started in 2010 with supporting our clients for medical device product registration services in Singapore. Since then, we have expanded the regulatory affairs service to including supporting clients for regional registration (example in Malaysia). We have expanded our reach to cover other major ASEAN countries  (example Indonesia; Philippines etc).  Our regulatory partner network now include Japan, South Korea and Taiwan and China.  We continue to be able to support our clients for complying with CE and US FDA.   We have also focus more and more to support clients involve in  IVD (both oncology and infectious diseases) and also SaMD.

Training Services

Besides consulting services, we all provide training to complement consulting work.  The training focuses mainly on, but not limited to, QMS (ISO13485;  21 CFR Part 820;  GDPMD); Risk management; Software life cycle development per IEC62304 and others.   Our Principal Consultant (HweeEe) occasionally conducts training on QMS (ISO13485 and 21CFR Part 820)  for  SGS training programs.     We are also working closely with WMDO to promote their online training platform.

Clinical Evaluation & Reimbursement Strategies

Work early with our global experts for clinical strategy development at MD-CLINICALS including reimbursement within target markets. Through a network of local experts, we make sure you optimize your market access strategy through quality monitoring and project management.