Management System Certifications
Zenith provides audit and certification services as per ISO 13485 Medical Devices – Quality Management Systems and ISO 9001 Quality Management Systems to organizations who are covered in the below mentioned Technical Areas of Medical Devices and In-Vitro Diagnostic.
Medical Devices Technical Area (IAF MD9) for ISO 13485 (Codes & Description of Technical Area)
A.1.1 – Non-active medical devices
General non-active, non-implantable medical devices
Devices for wound care
Non-active dental devices and accessories
Non-active medical devices other than specified above
A.1.2 – Active medical device (Non-implantable)
General active medical devices (non-implantable)
Devices for imaging
Devices for monitoring
Devices for radiation therapy and thermo therapy
Active (non-implantable) medical devices other than specified above
A.1.4 – In Vitro Diagnostic medical device (IVD)
Reagents and reagent products, calibrators and control materials for:
In Vitro Diagnostic Instruments and software
IVD medical devices other than specified above
A.1.5 – Sterilization methods for medical devices
A.1.6 – Devices Incorporating/Utilizing Specific Substances/Technologies
A.1.7 – Parts and Services
Zenith provides these audit and certification services under accreditation regime of Internationally recognised Accreditation Bodies.
For European market, CE mark certification services for Medical Devices and In-Vitro Diagnostic Devices are provided as per EC directive/s;
The CE mark audit and certification services are provided in co-operation with EU based and recognised Notified Bodies.
We have competent and adequate human resources in terms of Lead Auditors, Auditors and Technical Experts with commitment to provide effective and efficient audit and certification services, ranging from Quality Management Systems Certifications to Product Certifications confirming to various Standards, Practices and Code of Conduct.
Our audits empower organisations to monitor and update their business processes. This leads organizations to compete and grow at national and international levels.
Disclaimer: All the training programs are conducted at neutral venues. The training materials provided and taught during the training program are available in public domain. Customised training programs which may be misinterpreted as Consultancy are not provided.
Zenith Quality Assessors Pvt. Ltd. operates quality management system certification schemes, product certification schemes and testing activities under internally designated business divisions
Zenith Quality Assessors Pvt Ltd is always committed to continually maintain highest standard of business ethics and professional integrity in all its activities across the organization