Our Experienced and Enthusiastic Team of Professionals can support your organization to get following Certifications for your Devices from Accredited Certification Bodies in an efficient and Reasonably Shortest Possible Time and Cost-effective Manner. Below are few services provided by us:
Quality System Gap Assessment
ISO 13485 Quality System Implementation
ISO 13485 Quality System Transition
Standard Operating Procedure (SOP) Development
Document Control Implementation
Design History File Creation
Risk Management (ISO 14971)
Medical Device Single Audit Program (MDSAP) Readiness Audit
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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.