+1 302 2612614
+1 302 2612614
DIY ISO Documentation Kit for Medical Device Management System

Get manual, procedures, forms and other value adding services for ISO 13485

Save money and build your ISO 13485 Medical Device Management System with Do-It-Yourself(DIY) ISO documentation kit with value added services & 3 months FREE iCompliance MDMS software standard license

Standard Type Target Sectors Digital Transformation
ISO 13485 Horizontal All Scetors & Sizes icompliance.online

Standard Focus Areas
• Customer Focus to meet their needs and expectations
• Consistently producing products or services according to specifications
• Ensuring regulatory compliance
• Increased productivity and efficiency
• Access to new markets and higher market share

How to implement ISO 13485 with Documentation Kit
Establish, implement & get certified for ISO 13485 with pre-built documentation kit developed by highly competent and experienced professionals with hands-on experience of the quality management system in multiple industries sectors. The documentation kit includes: 1. Scope statement established in i-Scope in iCompliance
2. MDMS procedures, work instructions and guidelines established in i-Governance in iCompliance
3. MDMS policy and MDMS objectives established in iCompliance
4. MDMS forms and templates uploaded and readily available in iCompliance
5. MDMS folders established to record evidences in iCompliance
6. MDMS audit checklists established in iCompliance
7. MDMS non-conformities, customer complaints and other discripencies managed for iCompliance
8. Management Review agenda and outputs established in iCompliance
9. Multiple reports and analytical dashboards available for users of iCompliance pre-built documentation kit
DIY ISO Documentation Kit for Successful Certification

Some organizations like to use their own existing in-house resource to establish and implement ISO Management Systems and get successfully certified. iCompliance offers the right DIY ISO solutions which is proven, reduce implementation time & cost effective.

iCompliance DIY ISO Kit contains pre-compiled documented information including policies, procedures, templates, forms, registers and controls that will assist organizations in implementing ISO management system standards through the steps towards a successful certification audit. iCompliance DIY-ISO Kit is tried and tested in many real management systems, and been audited and certified by many certification bodies. All the good reasons to select DIY-ISO Documentation Kit offered by iComplaince.

  • Definite advantage of iCompliance All-in-one platform for ISO management systems
  • Flexibility in customizing mandatory and commonly used documented information in DIY ISO pre-compiled Documentation Kit and modifying them to meet your unique business requirements
  • 3 months FREE Standard license for iCompliance ISO Software to digitally implement your management system
  • Dedicated technical support representative to provide remote technical support and trainings for iCompliance software
  • Email support available from expert consultants
  • Optional remote consultation packages to get assistance from highly competent consultants to meet your support requirements on i-Consultancy in iCompliance marketplace. Consultants can work remotely with you, or even face-to-face and can be available on hourly or daily rates.
  • Optional certification packages from certification bodies accredited with UKAS, IAS , ANAB, etc in i-Certification in iCompliance marketplace
  • A series of tutorials and training documents to support at each step till certification.
  • One hour of live one-on-one online consultations with an ISO expert

Medical Device Management System

Selling Price
$399.50
How it works

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Select Standard

Choose suitable standard for your organization from iCompliance marketplace. You can contact iCompliance helpdesk to select the right solution for your industry and country.

Register as Member & get preview demo

Become a member and get access to entire document kit for preview. Also benefit from other privileges given to members including personalised dashboard and special member prices.

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Purchase what you need

Pay online based on your selection of specific documents or entire document kit. iCompliance save you from wasting money on documents or templates which you may already have. So you buy only what you need.

Select addition service

Leverage iCompliance platform for value added services like on-demand consultancy and certification from certification bodies listed on iCompliance platform

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Personalise Dockit

Modify the document as per your process practices. Customise manuals, procedures and templates with your logo, company name and other details in iCompliance platform.

Key Benefits

iCompliance offer DIY-ISO Documentation Kit is unique with benefits like...

  • Save Time
  • Save months of time & efforts for documenting, implementing & getting certified
  • Save Money
  • Save investments & Do-It-Yourself without engaging expensive consultants and specialists
  • Easy to Use
  • Built on iCompliance software makes easier to deploy and implement your documentation kit
  • Customisable
  • DIY ISO kit combine your company knowledge with best practices in personalized manner
  • Created by Experts
  • Kits developed by industry experts & senior consultants with hands-on industry experience
  • Compliance Ready
  • Comphrensive approach to fulfill regulatory & ISO standards compliance requirements
  • Personalized Documents
  • You can place your logo, company name & brand identity with easy to use setup in iCompliance
  • Successful Certification
  • DIY ISO kit make internal & external audit easier with checklists in i-Audit in iCompliance
  • Practical Implementation
  • Doing it yourself with expert guidance make effective implementation faster & easier
Select additional value-added services

One-stop-platform to get wide range of trainings, consulting, automation, certification and other solutions for Quality Management Systems

MDMS Trainings

iCompliance marketplace connect international trainers and training companies offering anything from face-to-face to e-Learning training solutions. Select 100s of courses including accredited & customized courses
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MDMS Consultancy

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MDMS Certification

Totally impartial technology platform connecting clients with independent accredited certification companies & registrars for their conformity assessments, compliance and certification needs at economical price.
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MDMS software

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