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.
Class A Medical Devices
Class B Medical Devices
Class C Medical Devices
Class D Medical Devices
Import Registration for Foreign Manufacturers and Indian Importers on MD-15
Indian Authorized Representative Services on MD-15
Manufacturing License on MD-9
Manufacturing License on MD-5
Loan License on MD-10
Loan License on MD-6
Test License on MD-12
Compliance to Legacy Devices
Transition from Legacy Devices to Registration Devices
Compliance to EU MDR 2017/745
Preclinical Testing Guidance
Biological Evaluation as per ISO 10993 Series of Standards
Biomechanical Testing of Orthopaedic Implants
Physicochemical Testing of Sterile Disposable Devices
General Safety Testing of Electro-Medical Devices
Compliance to QSR Requirements of 21CFR
Compliance to 510K Regulations
Sterilization Validation as per ISO 11135
Sterilization Validation as per ISO 11137 Part 1, Part 2 and Part 3
Sterilization Validation as per ISO 17665-1
Product Validations as per Applicable Standards
Process Validations as per Applicable Standards
Compliance to MDSAP Requirements for US, CANADA, AUSTRALIA, BRAZIL and JAPAN
ISO 14971:2019 Risk Management
Quality Management System Certifications
EN ISO / ISO 13485:2016 Certifications
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.
Objective: Hassle-Free Regulatory Approval for Indian Manufacturers, Foreign Manufacturers and Importers.