Health Care

Health care industry, is generally known as  medical industry which provides goods and services for treatment of patients. Treatment may be curative, preventive, rehabilitative, or palliative care.

But from management system point of view, the main groups that we deal with in our consulting are:

• Pharmaceutical industries
• Nutraceutical industries
• Medical devices manufacturers
• Drug design & development
• Regulatory management
• Hospitals and medical care
• Medical diagnostic centers
• Bio medical laboratories
• Bio waste management

ISO 13485

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Note : In markets influenced by US FDA, ICH Q10 is promoted as a model for Quality Management System

ICH Q10 model

The objective of ICH is to increase international harmonisation of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner. These activities have been undertaken to promote public health, prevent unnecessary duplication of clinical trials in humans, and minimize the use of animal testing without compromising safety and effectiveness.

• International Organization for Standardization (ISO) quality concepts
• includes applicable good manufacturing practice (GMP) regulations, and
• complements ICH “Q8 Pharmaceutical Development” and ICH “Q9 Quality Risk Management