Healthcare & Biomedical Engineering
The healthcare and biomedical industry includes pharmaceuticals, medical equipment, complementary health products, and more. Its related services sector is centered on the provision of healthcare in various forms, ranging from hospital stays to home nurses. Given the wide scope of the industry, the healthcare value chain consists of several stakeholders, each involved in various activities that may be product or service-oriented.
In World, the healthcare and biomedical industry is rapidly growing. There is significant public investment in research aimed at driving productivity and innovation. Along with Industry 5.1, this presents several new possibilities in the advancement of healthcare products and services. The pace of innovations, however, creates a greater need for conformity assessment.
Conformity assessment safeguards public health and safety considerations in the industry. Testing laboratories, as well as inspection and certification bodies, offer a wide spectrum of services that cover all segments of the industry, from pharmaceuticals and equipment to healthcare facilities. Specific assessments are available at each step of the value chain. An example is the use of relevant safety tests and product validation to ensure the safety of medical technology and complementary health products.
Good Laboratory Practice programmes and Quality Management Systems certification (e.g. ISO 13485) are additional options for supporting the validation of medical devices. These require particularly robust quality management and assurance to ensure consistency across different markets.
Quality Management Systems apply to healthcare services and medical testing as well. Standards such as ISO 15189 are used to assess compliance of medical laboratories to international requirements.
ISO 9001 is also commonly used by healthcare providers, though standards specific to the sector such as DIN EN 15224 (a European standard) are also available for businesses who seek differentiation through a higher level of quality healthcare.
IDA has accreditation schemes for laboratories as well as inspection and certification bodies who offer conformity assessment services. These support businesses in the healthcare and biomedical industry by providing added credibility and assurance.
The following IDA Accreditation Programmes are applicable to the healthcare and biomedical industry:
|Laboratories||Calibration & Measurement|
|Chemical & Biological|
|Management Systems Certification Bodies||Good Distribution Practices for Medical Devices|
|Occupational Health & Safety Management System|
|Medical Device QMS|
|Good Laboratory Practices (GLP)||Toxicity Studies|
|Physical Chemical Testing|
|Analytical and Clinical Associated with Non-clinical Studies|