Healthcare, Life Sciences, and Medical Devices
Certifications
Hospitals, research facilities & medical device manufacturers in India make sure to meet strict safety & quality demands through compliance certification services offered to the healthcare, life sciences, and medical device industries. These certifications act like promises that everything is safe and efficient for patients. This includes hospital procedures, and medical equipment too. Inspectors check processes, equipment, and facilities to ensure they follow regulations (by inspecting them thoroughly).
Manufacturers and healthcare providers can demonstrate their commitment to producing safe medical devices and reliable healthcare services by earning certification. It’s a way of assuring us that high standards of quality & safety are maintained when visiting hospitals or using medical equipment.
Certifications Organization
- ISO 9001:2015 - Quality Management System
- ISO 13485:2016 - Medical Devices Quality Management System
- European Conformity (CE Mark) Certification
- Food and Drug Administration (FDA) Registration
- Health Insurance Portability and Accountability Act (HIPAA) Compliance
- Food Safety and Standards Authority of India (FSSAI) License
- Fire Safety Certificate issued by the Chief Fire Officer
- Good Manufacturing Practice (GMP)
- Pharmaceutical Inspection Convention
- Occupational Safety and Health Administration (OSHA) Compliance Certification
- Joint Commission Accreditation
- Centers for Medicare & Medicaid Services (CMS) Compliance Certification
- National Accreditation Board for Testing and Calibration Laboratories
- European Medicines Agency (EMA) Approval
- Clinical Laboratory Improvement Amendments (CLIA) Compliance Certification
- Authorization for Organ Transplantation from the State Government
- Biomedical Waste Management Authorization from the Pollution Control Board
- Accreditation Commission for Healthcare (ACHC) Accreditation
- Joint Commission International (JCI) Accreditation
- Certificate of Registration under the Clinical Establishments
Certifications Personnel
- Clinical Laboratory Improvement Amendments (CLIA) Certification
- Certified Professional in Healthcare Information and Management Systems (CPHIMS)
- Health Insurance Portability and Accountability Act (HIPAA) Training Certification
- Health Level Seven (HL7) Certification for Electronic Health Records (EHR)
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