ISO 13485/21 CFR 820
Know-how set

This know-how set defines an ISO 13485:2016, 21 CFR 820, ISO 14971:2019, and ISO 62366-1:2015 compliant Quality Management System (QMS). It can be used by an organization involved in one or more life cycle stages of medical devices.

Description

Find out more about the know-how set

QMS complete documentation

This know-how set contains the documentation required to define and operate an ISO 13485 / 21 CFR 820-compliant Quality Management System. It includes policies, processes, procedures, instructions, document templates, normative sources, roles, and other types of content that comprise the systematic approach to any organization engaged in medical device or in vitro diagnostics medical device product activities. 

Normative sources

The know-how set documentation was derived from and is linked to the following normative sources: ISO 13485:2016, 21 CFR 820, 21 CFR 830, ISO 14971:2019, IEC 62304-1:2015, EU 2017/745 (MDR), and EU 2017/746(IVDR). Each normative source has a list of the documentation from this know-how set used to prove compliance. The organization can add its regulations or standards.

Role-based training

The know-how set introduces fundamental roles the QMS requires on quality management and product life cycle levels. The roles define the scope of the training/awareness building concerning the QMS definition. By assigning a person to a role on ins2outs, you limit their perspective to only essential information. The know-how set uses the ins2outs acceptance tasks functionality to keep training and awareness-building records.

Ready-to-use and structured for medical devices

The know-how set content is ready to use. It indicates the elements which should be tailored for the organization’s specificity using the TODO: strings. Thanks to this approach, you can focus on implementing the QMS, not defining all its elements. The know-how set also establishes a structure of the QMS documentation, introducing order to the system on both quality and product life cycle levels. The system offers the default structure for medical device documentation linked with the appropriate templates (ins/outs).

Know-how set elements

Click on each of the groups to expand and see the complete list

QMS Elements (170+)

3 - Policies

  1. PLC Quality Manual
  2. PLC Quality Policy
  3. PLC Risk Management Policy

11 - Processes

  1. PLC Clinical Evaluation Process
  2. PLC Post-market Surveillance Process
  3. PLC Vigilance Reporting Process
  4. PLC Competencies Management Process
  5. PLC Audit Management Process
  6. PLC Complaints Handling Process
  7. PLC Management Review Process
  8. PLC Product Realization Process
  9. PLC Product Usability Engineering Process
  10. PLC Purchase Management Process
  11. PLC Risk Management Process

32 - Procedures

  1. PLC Competencies and Awareness Management Procedure
  2. MS Control of Records Procedure
  3. MS Control of System Documents Procedure
  4. PLC Analysis of Data Procedure
  5. PLC Audit Management Procedure
  6. PLC Clinical Evaluation Procedure
  7. PLC Clinical Performance and Post-Market Surveillance Procedure
  8. PLC Control of Design and Development Changes Procedure
  9. PLC Control of Monitoring and Measuring Equipment Procedure
  10. PLC Control of Product Life Cycle Documents Procedure
  11. PLC Design and Development Outputs Transfer to Manufacturing Procedure
  12. PLC Design and Development Procedure
  13. PLC Issuing Advisory Notice Procedure
  14. PLC Management of Nonconforming Product Procedure
  15. PLC Management Review Procedure
  16. PLC Managing Complaint Handling Procedure
  17. PLC Managing Customer Feedback Procedure
  18. PLC Managing Rework Procedure
  19. PLC Nonconformities and Corrective Actions/Preventive Actions Management Procedure
  20. PLC Operations for Labelling and Packaging
  21. PLC Procedure for Validation of Application of Computer Software
  22. PLC Procedure to Monitor and Control Work Environment
  23. PLC Product Identification Procedure
  24. PLC Product Processing, Storage, Handling and Distribution Procedure
  25. PLC Product Release Authorization Procedure
  26. PLC Product Servicing Activities Procedure
  27. PLC Product Traceability Procedure
  28. PLC Production Control Procedure
  29. PLC Purchase and Suppliers Management Procedure
  30. PLC Reporting to Regulatory Authorities Procedure
  31. PLC Returned Product Identification Procedure
  32. PLC Validation of Processes Procedure

0 - Instructions

If needed organization can create its own instructions. 

99 - Ins/Outs (including Templates)

  1. PLC Acquisition Minor Order
  2. PLC Adverse Event
  3. PLC Audit Plan
  4. PLC Audit Programme
  5. PLC Audit Report
  6. PLC Benefits Assessment
  7. PLC Change Request
  8. PLC Clinical / Performance Evaluation Report
  9. PLC Clinical Evaluation Plan
  10. PLC Competencies Evaluation
  11. PLC Complaint Record
  12. PLC Corporate Identity Brandbook
  13. PLC Corrective Action
  14. PLC Customer Property
  15. PLC Design and Development File
  16. PLC Design and Development Inputs
  17. PLC Design and Development Outputs
  18. PLC Design and Development Plan
  19. PLC Design and Development Project Charter
  20. PLC Design and Development Review
  21. PLC Design and Development Transfer Record
  22. PLC Design History File (DHF)
  23. PLC Device History Record (DHR)
  24. PLC Device Master Record (DMR)
  25. PLC Document Template
  26. PLC Documenting Equivalence
  27. PLC Education, Training, Skills and Experience Record
  28. PLC EU Declaration of Conformity
  29. PLC Field Safety Corrective Action (FSCA)
  30. PLC Field Safety Notice (FSN)
  31. PLC Formative Evaluation Plan
  32. PLC Formative Evaluation Summary  Report
  33. PLC Infrastructure Qualification Records
  34. PLC Infrastructure Requirements
  35. PLC Installation Requirements
  36. PLC Instructions for Use
  37. PLC Intended Purpose
  38. PLC Letter of Appointment Person Responsible for Regulatory Compliance (PRRC)
  39. PLC Literature Search Protocol
  40. PLC Maintenance Activities Record
  41. PLC Maintenance Activities Requirements
  42. PLC Management Review Report
  43. PLC MDR General Safety and Performance Requirements – Statement of Applicability
  44. PLC Medical Device File
  45. PLC Monitoring and Analysis
  46. PLC Nonconforming Product Record
  47. PLC Nonconformity (NCR)
  48. PLC Opportunity for Improvement (OFI)
  49. PLC Periodic Safety Update Report (PSUR)
  50. PLC Post-market Clinical Follow-up Evaluation Report (PMCFR)
  51. PLC Post-market Clinical Follow-up Plan (PMCF)
  52. PLC Post-market Surveillance Plan
  53. PLC Post-market Surveillance Report
  54. PLC Preventive Action
  55. PLC Process Tailoring
  56. PLC Product Cleanliness and Contamination Control Requirements
  57. PLC Product Communication Management Plan
  58. PLC Product Management Plan
  59. PLC Product Release Authorization Record
  60. PLC Product Release Authorization Under Concession Record
  61. PLC Product Requirement Template
  62. PLC Product Requirements
  63. PLC Product Requirements Review Record
  64. PLC Product Requirements Specification (PRS)
  65. PLC Product Version
  66. PLC Project Competencies Development Plan
  67. PLC Purchased Product Verification Records
  68. PLC Purchasing Information
  69. PLC Quality Management Plan
  70. PLC Record of Installation Activities
  71. PLC Records of Process Validation
  72. PLC Records of Servicing Activities
  73. PLC Regulatory Strategy
  74. PLC Reporting to Regulatory Authority Record
  75. PLC Residual Risk Evaluation
  76. PLC Risk Assessment
  77. PLC Risk Management File
  78. PLC Risk Management Plan
  79. PLC Risk Management Report
  80. PLC Risk Management Review Record
  81. PLC Serious Incident
  82. PLC Special Storage Conditions Records
  83. PLC State of the Art
  84. PLC Summary of Safety and Clinical Performance
  85. PLC Summary of Safety and Performance
  86. PLC Summative Evaluation Plan
  87. PLC Summative Evaluation Summary Report
  88. PLC Supplier Agreement
  89. PLC Supplier Evaluation Record
  90. PLC Technical Documentation
  91. PLC Test Execution Summary Report
  92. PLC Test Level Execution Report
  93. PLC Test Plan
  94. PLC Traceability Records
  95. PLC Usability Engineering File
  96. PLC Verification and Validation Strategy
  97. PLC Work Environment Requirements
  98. PLC Yearly Competencies Development Plan

13 - Normative sources

  1. PLC EU: General Data Protection Regulation
  2. PLC ANSI/AAMI HE75:2009/(R)2018
  3. PLC CA: SOR/98-289
  4. PLC EU: 2017/745 (MDR)
  5. PLC EU: 2017/746 (IVDR)
  6. PLC IEC 62304:2006
  7. PLC IEC 62366-1:2015
  8. PLC ISO 13485:2016
  9. PLC ISO 14971:2019
  10. PLC ISO 15223-1:2021
  11. PLC US: 21 CFR 820
  12. PLC US: 21 CFR Part 830
  13. PLC US: Applying Human Factors and Usability Engineering to Medical Devices

16 - Roles

  1. PLC Contractor
  2. PLC Employee
  3. PLC Human Resources Manager
  4. PLC Internal Auditor
  5. PLC Top Management
  6. PLC Clinical Expert
  7. PLC Designer
  8. PLC Person Responsible for Regulatory Compliance
  9. PLC Product Manager
  10. PLC Product Team Member
  11. PLC Production Manager
  12. PLC Project Team Member
  13. PLC Quality Assurance Manager
  14. PLC Quality Manager
  15. PLC Service Provision Manager
  16. SDLC Project Manager

How to purchase?

The purchase process is straightforward

Buying the know-how set

To buy a know-how set, you must order it using the contact form below. ins2outs would issue an invoice that covers the one-time payment for the know-how set. After the payment, ins2outs copies the know-how set to the organization’s account on ins2outs. The account must be active and have at least one paying user assigned. From that moment on, the know-how set is available for your organization. It usually takes one hour to copy the know-how set once the payment is confirmed.

Know-how set license

Once purchased, ins2outs grants your organization authorization for non-exclusive use of the Know-how set (non-exclusive license). The license is given in return for a one-time fee for the know-how set for the current status of the set. The license is granted for an indefinite period. The know-how set cannot be resold or made available outside the purchasing organization. The license limitations are documented in the Terms and Conditions document chapter “VI. Know-how set license”.

Ten hours of free consulting

When you purchase this know-how set on ins2outs, you are entitled to ten hours of free consulting. The purpose of that support is to smoother your entry into the ins2outs platform, show how to use ins2outs effectively, and let you test how a quality manager as a service offering could look. You define the schedule and the topics for which this consulting can be used. To prolong that service, try our Quality Manager as a Service (QMaaS) offering.

Benefits

Explore the benefits of starting your system definition with this know-how set

Deliver know-how to your organization in one hour

Acquire the ISO 13485 / 21 CFR 820 know-how set instantly from the ins2outs platform. Let your organization gain the know-how, medical device-related processes and build the necessary competencies.

Shorten by up to 75% your QMS implementation time

The QMS implementation can be a prompt and effective process. Combine ins2outs software, ISO 13485 / 21 CFR 820 know-how sets, and our consultants to define and certify any management system in weeks, not years.

Minimize the QMS project risk

Bringing ins2outs, the know-how set and our consultant triad can bring the project execution risk to nearly zero. You get your QMS faster, more efficiently, and earlier to start generating revenue from your medical devices on the market.

Shorten medical device market approval

It takes excellent coordination of intended purpose definition, product management activities, and managing notified bodies or market regulators to place a medical device on the market promptly. Shorten your path to market with experts.

Build a QMS targeting the global markets

The ISO 13485 / 21 CFR 820 know-how set has been developed with the placing of MD / IVD MD products on the global markets. The know-how set targets at least the EU, US, and Canadian markets. ins2outs allows its flexible extension to any other regulatory regime.

Pricing

Quality Manager

6500/month
  • Experienced Quality Manager
  • Delivered via ins2outs
  • Monthly net fee
  • For organizations with up to 50 users

ins2outs Software

20/active user/month
  • Cloud-hosted
  • Requires one active user account
  • Standard features package
  • Full view and edit rights

Check our complementary services

ins2outs software

An organization works in ins2outs software (SaaS) hosted in a secure cloud environment. ins2outs provides an account where any of its management systems are hosted, like quality, information security, privacy, and others. The organization invites its users to the ins2outs software.

Quality Manager as a Service (QMaaS)

Quality Manager defines, supervises, and operates your ISO 13485 and 21 CFR 820-compliant Quality Management System (QMS). The consultant will lead your QMS certification and support market approvals of your medical devices.