ISO 13485 Consulting for Any Business

ISO 13485 Consulting for Small, Medium & Large Businesses

Kelmac Group specializes in helping any organization become ISO 13485 compliant or achieve ISO 13485 Certification. We provide over 14 years’ experience in 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.

ISO 13485:2016 is an internationally recognized standard for Quality Management for the Medical Device Industry designed to help manufacturers comply with regulatory systems and understand what they need to do to place compliant devices on markets throughout the world.

We have worked in over 46 countries around the globe, with organizations of all types including many leading multinationals. For 2018, we are introducing a new service specifically for Small Businesses.

The below consulting options are available.

  • Onsite Share The Work

    For: Small Businesses

    Best option for companies that want onsite support but want to undertake a significant role
    • Divided Workload
    • Provided remotely and onsite
    Service Includes:
    • Dedicated Consultant
    • Onsite Gap Analysis
    • Detailed Project Plan
    • Management Team ISO 13485 Training
    • Sample set of ISO Documents
    • Coaching & Mentoring Calls with Consultant
    • ISO Document Review/Preparation
    • Internal Audit Preparation
    • Onsite Internal Audit
    • Registrar Coordination
    • On Call Support for Registrar Audit

    *3 Month Program

  • Onsite Full Service

    For: Small Businesses

    Best option for companies that want the consultant to do the majority of the work as they may have limited resources or a tight deadline for certification.
    • Majority Workload [80%]
    • Provided remotely and onsite
    Service Includes:
    • Share The Work Plus
    • Project Management & Coordination
    • Professional Documentation Development
    • Guidance in identifying the statutory and regulatory requirements including other legal obligations
    • Validations Guidance
    • Post Market Surveillance Guidance
    • Communications & Reporting Support
    • Host Management Review (Onsite)
    • Implementation Support (Onsite)

    *3 Month Program

  • Onsite Bespoke Consultancy

    For: Any Organization

    Best option for any organization looking for bespoke consulting support.
    • Full Consulting Support based on specific client needs
    • Provided remotely and onsite
    Support Options available:
    • Dedicated Consultant Team
    • Project Management & Coordination
    • Kelmac Group® 9-Step Model & One System Methodology
    • Comprehensive Coaching & Mentoring
    • Bespoke Documentation Development
    • Full Implementation Support
    • Full Certification Support
    • Performance Analytics

Why Choose Kelmac Group® Consulting

  • Proven Track Record Since 1996 we have helped many organizations achieve successful ISO certification. We have a 100% success record.
  • Unmatched Experience Unmatched Experience Unlike many of our competitors, we have worked with clients in over 46 countries around the globe from small to medium businesses, government & non-profit organizations including up to Fortune 500 companies.
  • Flexible Options Each client decides the best support package to meet their needs. We offer all clients a range of support options geared towards providing the support YOU want, built around your specific needs & preferences.
  • Fixed Fee We understand how important it is to have confidence and certainty when financially planning for ISO Certification. All projects are fixed fee to ensure that there are no surprises.

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