Quality Assurance: ISO Certification-13485:2016 / EN ISO 13485:2016, MDSAP

Quality Assurance ServicesOur 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 Controls
  • Design History File Creation
  • Risk Management (ISO 14971)
  • Readiness Audits
  • Medical Device Single Audit Program (MDSAP) Readiness Audit

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