Our Services
We provide consultancy services on the design & development, manufacturing, distribution and product registration for medical devices. We also provide Regulatory Affairs and Quality Assurance guidance pertaining the Total Product Life Cycle of medical devices.
Our services comprise: advising on Quality Management Systems (QMS), Regulatory Affairs, and providing training services for both QMS and Regulatory Affairs.
Regulatory Affairs Consulting
A wide array of Medical Devices
- General Medical Devices
- Single-use Devices
- Implants
- Sterile Devices
- Electro-mechanical Devices
- In Vitro Diagnostics (IVD)
- Test kits
- Software Systems
Wide Global Coverage
- ASEAN Countries
- Australia: Therapeutic Goods Administration (TGA)
- China
- Europe: Conformité Européenne (CE) Medical Device Regulation (MDR) / In Vitro Diagnostic Regulation (IVDR)
- Japan
- South Korea
- United States of America: Food and Drug Administration (FDA)
QMS Consulting
Quality Management Systems
- International Organization for Standardization ISO13485
- 21 CFR Part 820 Quality System Regulation
- Good Distribution Practice for Medical Devices (GDPMD)
Training
Led by our Principal Consultant
- Quality Management Systems
- Regulations
- Risk management
- Design & development
- V&V
Others
Other Consultancy Services
- Risk Management Consulting Services (ISO14971)
- Software Life Cycle (IEC 62304)
- Usability Studies
- Regulatory Advice to Support Clinical Trials
DH RegSys 