Healthcare Standards and Regulations (BME217)

The course aims to provide students with a general understanding of a healthcare regulation as it exists in Singapore with relevant emphasis on regulation that pertains to biomedical engineering. There will also be a brief overview of relevant foreign examples such as FDA, CE etc. Students would also be given an introduction into international health standards and accreditation systems.

• International Pharmaceutical and Drug Development
• Regulation of Western Medicine in Singapore
• Goods and Manufacturing Practices (GMP)
• Validation for Drugs
• International Regulation for Medical Devices
• Classification of Medical Devices
• Healthcare standards in hospitals
• Joint Commission International (JCI) certifications
• Risk management
• Business continuity planning
• Emerging issues in Healthcare Standards and Regulations (Part 1)
• Emerging issues in Healthcare Standards and Regulations (Part 2)

• Discuss the role and operations of regulatory bodies in Singapore and worldwide
• Examine the role of legislation, regulations, principles of cGMP and guidance in healthcare industry
• Apply knowledge of the common healthcare standards required in the industry
• Explain the use of a framework on what is required for licensing of a medical devices
• Design a checklist on audit of healthcare standards in the hospital
• Develop a risk assessment and business continuity project at workplace