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 : info.in@tuvsud.com

Website: www.tuvsud.com/en-in

TÜV SÜD South Asia Solitaire, 4th Floor, ITI Road, Aundh, Pune – 411007 Maharashtra

Comments

comments