ISO 13485 Consulting ​

Introduction

ISO 13485 Certification is the world’s most accepted and followed international Quality Management System (QMS) standard by the medical device industry. QMS is designed to help manufacturers comply with regulatory systems and understand what they need to do to place compliant devices on markets throughout the world. It is a collection of policies, processes, documented procedures, and records to be followed by an organization. 

The most important point about ISO 13485 is that it is often used in a regulatory environment. Medical device manufacturers use it to implement an effective management system to meet regulatory requirements of the most of the countries.

RBridge is specializes in helping organizations become ISO 13485 compliant and achieve ISO 13485 Certification. We do quality consulting for the Medical Devices Industry to offer you expert guidance & know-how, coaching & mentoring, online and onsite training, templates and everything you need to achieve ISO 13485 Certification. We help in creation of the SOPs, work instructions, Quality Manuals, VMP’s, Process Validation documentation etc. In the next phase, we assist to implement the system at shop floor and provide the need-based training to make sure that the system is adequately implemented.

Regulatory Services

  • Drugs
  • Medical Device
  • Diagnostic kit
  • Food Regulatory Services​
  • Cosmetics
  • Biological
  • CRO

Regulatory Intelligence

  • Country
  • Category
  • News
  • Regulation / Guidlines

Publishing and Submission

  • Global eCTD submission Publishing and submission services
  • Nees Submission
  • Category
  • Medical Device
  • Active substances master file Submission
  • Certificate of suitability Submission (CEP)

About

A full Portfolio of Capabilities to deliver Measurable Results for clients Regulatory affairs Market intelligence and filing strategies. Regulatory filings at USA/ EU/ Emerging Markets Emerging Market Tender activities and support to participate thru capable distributors & facilitators

Services

  • Drugs
  • Cosmetics
  • Biological
  • Medical Device
  • Diagnostic Kit
  • Food Regulatory Service
  • CRO

Contact

Rbridge Lifesciences Pvt Ltd

  • info@rbridge.in
  • maya.singh@rbridge.in
  • santosh.savarkar@rbridge.in
  • 8980031110
  • 7977768788
Open chat
Powered by