DKNSB provides Consulting Service for Medical Device Industry

Our Team of Experts includes Healthcare Professionals, Regulatory Compliance Consultants and Doctors. We focus on providing service in minimum possible time and cost effective way.
 
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Licenses ISO Certifications CE Marking Authorized Representative Services
 
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Import Registrations Export Registrations Document Writing Facility Designing
 

 

MEDICAL DEVICE REGULATORY CONSULTING SERVICES

Medical Device and IVD Manufacturing Companies are required to Comply with Schedule-M of Drugs and Cosmetics Act of India, Medical Device Rules 2017 (India), European Medical Device Directives, EU MDR,  IVDR 2017-746, MDDR 2017-745, ISO 13485 and US FDA Quality System Regulations.

We understand that becoming conversant with CDSCO, European Regulations and US FDA Regulations can be very challenging.

We provide Solution Based Services for: 

  • Global Regulatory Strategies Development.
  • Medical Device Registration and Approval in India with CDSCO (Form 41)
  • Medical Device Manufacturing License for Indian Manufacturer (Form 28)
  • Import License for Indian Medical Device Importer (Form 10)
  • CE Marking / European MDD and IVDD Compliance
  • FDA 510(k) Notifications / PMA Submissions
  • CMDR Compliance and Licensing
  • Indian Authorized Agent / Representative for Foreign Manufacturers
  • Device Master File Preparation and Maintenance
  • Plant Master File Preparation and Maintenance
  • Global Medical Device Approval and Registration

MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM IMPLEMENTATION AND CERTIFICATION CONSULTING SERVICES

We also provide Specialized Services that are as follows:

  • Global Quality System Development, Implementation and Certification (ISO 9001 / ISO 13485 / US FDA QSR / CMDR / JPAL / MDD / GMP / CFR)
  • Risk Analysis and Risk Management for all Classes of Medical Devices and IVDs as per ISO 14971 requirements.
  • Clinical Evaluation as per Meddev 2.7.1 Rev. 4 and ISO 14155 requirements
  • Design Control Documentation Design History File (DHF)
  • Sterilization Method Validation and Documentation as per ISO 11135, ISO 11137, ISO 17665 requirements
  • Clean Room Validation Documentation and Methods as per ISO 14644 series of Standards
  • Medical Device Packing Validation Documentation Requirements and Method of Validation as per ISO 11607-1 and ISO 11607-2 requirements
  • Medical Device Post Market Surveillance and Vigilance Requirements
  • Cleaning method Validation Document Requirements and Method of Validation

 

 
 
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#78, First Floor Pocket J,
Sector 4, DSIDC Industrial Area,
Bawana-110039 New Delhi, INDIA