HEALTHCARE AND MEDICAL DEVICES SERVICES LISTING

For over 30 years, TÜV SÜD has provided market access solutions and expert partnership for manufacturers and suppliers of medical devices and in vitro diagnostics. Our services put your product through its paces and ensure medical device market approval and acceptance.
We have in-depth knowledge of the medical devices and IVD market and our dedicated team of over 700 experts, engineers, and medical doctors provide assessments that cover the full life cycle of your products. We are global, multilingual and have experts in all major markets who provide tailored advice for ensuring your medical devices are approved and accepted. Read more about our testing services for medical devices below.
Market Approval and Certification
Europe
Medical Device Regulation (MDR)
In Vitro Device Regulation (IVDR)
Medical Devices Directive (MDD)
Active Implantable Medical Devices Directive (AIMDD)
CE Marking of In Vitro Diagnostic Directive (IVDD)
Unannounced Audits
Restricted Hazardous Substances
Americas
Medical Device Registration in Brazil
Medical Device Licences in Canada
Medical Device Single Audit Program (MDSAP)
Quality Management System Inspections under 21 CFR 820
Asia Pacific and Australia
Australia Therapeutic Goods Regulations
Regulation of Medical Devices in India
Medical Devices and Compliance with Japan’s PAL Regulations
Obtaining Korean Approval for Medical Devices
Registration Requirements for Medical Devices in Malaysia
Medical Device Regulations Under Singapore’s Health Products Act
Approval of Medical Devices in Taiwan
Russia
Approval of Medical Devices in Russia
Ukraine
Approval of Medical Devices in Ukraine
Overview
Medical Device Market Approval and Certification
Medical Device Testing and Assessment
Physical Testing of Medical Devices
Electrical Safety Testing (IEC 60601-1)
Functional Safety
EMC Testing
Environmental Testing
NRTL
IECEE CB Scheme
Chemical/Biological Testing of Medical Devices
ISO 10993-1 Biological Evaluation and Biocompatibility
Biocompatibility Testing for Medical Devices
Microbiological Testing for Medical Devices
Chemical Testing for Medical Devices
Cyber Security in Medical Devices
Cyber Security Testing and Assessment Service
Overview
Medical Device Testing and Assessment
Quality Management and Quality Control
ISO 13485 Quality Management System for Medical Devices
ISO 15378 Quality Management System for Medicinal Packaging Materials Suppliers
ISO 14971 Risk Management Requirements for Medical Devices
Quality Management and Quality Control for Medical Devices
Clinical Services
Clinical Data for Medical Devices
Assessment of Clinical Evaluation
ISO 14155 Clinical Investigation Plans for Medical Devices
Clinical Services
Healthcare
Good Dialysis Practices (GDP) Certification
ISO 27001 Management System Certification
Healthcare
Other Services
Orthopedic Medical Devices
Cardiovascular Medical Devices
Code of Conduct
MDR/IVDR Declaration of Interest
Med-Info Download Center
Questionnaires and Application Forms for Medical Devices
Regulatory Strategy
Transfer to TÜV SÜD
Contact Us
Get in touch with TÜV SÜD South Asia to know more about the Product Safety and Conformity Representative Training in India.
Phone: +91 20 6684 1212
Email : [email protected]
Website: www.tuvsud.com/en-in
TÜV SÜD South Asia Solitaire, 4th Floor, ITI Road, Aundh, Pune – 411007 Maharashtra