DKNSB Medical Device Consultants is backed by 20 years of experience with the aim to provide Technical and Regulatory Support to Medical Device Manufacturers from India and Overseas. We are a group of diversified, global Medical Device Regulatory Affair and Quality Management System Consultants focused on developing and delivering Best Regulatory Strategy, Quality Management System and Training services for Medical Device Manufacturers Globally. We cater to almost all segments of Medical Device Industry with emphasis on Implantable Devices, Sterile Single Use Disposable Devices, Active Therapeutic Devices, Active Diagnostic Devices, In-vitro Diagnostic Devices. The Devices can be from Low Risk, Moderate Risk, High Risk or Life Saving Devices, We provide Expert Services for Regulatory Compliances for All Classes of Medical Devices.


Hassle-Free Regulatory Approval for Indian Manufacturers, Foreign Manufacturers and Importers.


To Earn Customer Loyalty Through Regulatory Approval Services with Due Diligence and Maintaining Highest level of Professionalism and Ethical Approach in Regulatory Approval Consultancy Services.

Services Offered

Indian Regulations

Class A Medical Devices

Class B Medical Devices

Class C Medical Devices

Class D Medical Devices

  1. Import Registration for Foreign Manufacturers and Indian Importers on MD-15
  2. Indian Authorized Representative Services on MD-15
  3. Manufacturing License on MD-9
  4. Manufacturing License on MD-5
  5. Loan License on MD-10
  6. Loan License on MD-6
  7. Test License on MD-12

EU Regulations

  1. Compliance to Legacy Devices
  2. Transition from Legacy Devices to Registration Devices
  3. Compliance to EU MDR 2017/745

Preclinical Testing Guidance

  1. Biological Evaluation as per ISO 10993 Series of Standards
  2. Biomechanical Testing of Orthopaedic Implants
  3. Physicochemical Testing of Sterile Disposable Devices
  4. General Safety Testing of Electro-Medical Devices

US Regulations

  1. Compliance to QSR Requirements of 21CFR
  2. Compliance to 510K Regulations


  1. Sterilization Validation as per ISO 11135
  2. Sterilization Validation as per ISO 11137 Part 1, Part 2 and Part 3
  3. Sterilization Validation as per ISO 17665-1
  4. Product Validations as per Applicable Standards
  5. Process Validations as per Applicable Standards

MDSAP Regulations

Compliance to MDSAP Requirements for US, CANADA, AUSTRALIA, BRAZIL and JAPAN

Risk Management

ISO 14971:2019 Risk Management

Quality Management System Certifications

EN ISO / ISO 13485:2016 Certifications