Need of ISO 13485:2016

Why need of Medical Device Quality Management System is Important?

  • Increase the possibility of producing safe and effective medical devices.
  • Comply with regulatory requirements.
  • Meet or exceed customer expectations.
  • Assist in monitoring the supply chain's efficiency.
  • With just one audit, you can enter any major market in the globe.
  • Improved risk management and design controls to help clients develop and improve their products.
  • Increased efficiency in supporting customers in obtaining market clearance and approval in order to accomplish ambitious sales and marketing targets.
  • Ensure compliance with the standard's standards and more.
  • Gain potential entry into overseas markets because ISO 13485 accreditation is seen as a first step toward meeting European criteria.

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Is it complex to implement MDQMS in your organisation ?

It is not that much complex to implement ISO standard. A proper guidance and a proper training can help in organization to implement. ISO 13485 implementation shows company follow the proper regulation and norms according to the standard that eventually meets the basic requirement of customer satisfaction. It helps to ensure the quality output maintenance of medical devices, Risk Management etc.

  • Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.
  • Starting with management support and identifying the customer requirements for the QMS, you will need to start developing documentation including the
    • Quality Policy
    • Quality Objectives
    • Quality Manual.

OUR CORE SERVICES

Third Party Certification/Assessment

BSCIC aims to provide Impartial and on time 3rd Party Auditing services accredited by JAS-ANZ, NABCB, IAS & EIAC.

Management Systems Training

Our Lead Auditor courses accredited by CQI-IRCA & Exemplar global are instructor -led offered both virtually and physically as per the client's requirement.

Third Party Inspection

BSCIC's main purpose of inspection is to provide the client with objective, independent, and impartial information with quality.

Why Choose US ?

BSCIC is established as an independent Conformity Assessment Body and Training Organization with its main objective to provide its ISO Certification services in the domains of Quality Management System, Environmental Management System, Occupational Health & Safety Management System, Food Safety Management System, HACCP, Information Security Management System, Business Continuity Management System, Information Technology- Service Management System, Medical Devices-Quality Management System, GMP-Cosmetic Products, Energy Management System and Risk Management. BSCIC is established as a professional organization backed by devoted, highly qualified and experienced Assessment, Training and Certification personnel offering a wide spectrum of normative/ customer-oriented Certification and Training services in an efficient and cost effective manner etc.

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BENEFITS

Benefits of ISO Certification

  • Operational Efficiency
  • ISO certification helps in building customer satisfaction and improving operational efficiency internal and external to the organization.
  • Increase
    Business
  • ISO Certification helps businesses entity win public and private contracts thus widening the scope of potential clients.
  • Customer Satisfaction
  • A certified quality management system demonstrates entity commitment towards its Management System.
  • Cost Effective
  • ISO certification helps organizations to reduce wastage, improve working culture, ensure best practices and so on and thus helping in reducing the overall cost.

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We are devoted to understanding our client's needs and providing relevant solutions with high-quality execution. We think that effective and appropriate health, safety, and environmental management may result in considerable corporate benefits while also being the right thing to do.

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