ISO 13485:2016 Exclusive Department SOPs

Freyr’s exclusive departmental SOPs include all the department/function specific SOP which are designed to meet all your ISO 13485:2016 needs. It is tailored specifically to your departmental requirements for your medical device(s), for effective QMS at your organization.

Didn't find the department you were searching for? Worry not. Connect with our experts today.

Key Features

  • End to end Solution

  • Customisable Toolkit

  • Includes 90+ Templates and Procedures

  • Cost Efficient

Design & Development

  • Design and Development Procedure
    Price
    $300.00
    Select Templates
  • Purchase the entire Design & Development Department SoP package
    Price
    $300.00

Engineeering

  • Calibration
    Price
    $140.00
    Select Templates
  • Purchase the entire Engineering Department SoP package
    Price
    $140.00

HR

  • Training, Awareness & Competency Procedure
    Price
    $220.00
    Select Templates
  • Purchase the entire HR Department SoP package
    Price
    $220.00

Identification

  • Identification and Traceability Procedure
    Price
    $120.00
    Select Templates
  • Purchase the entire Environment Department SoP package
    Price
    $120.00

Internal audit

  • Internal Audit Procedure
    Price
    $160.00
    Select Templates
  • Purchase the entire Internal audit Department SoP package
    Price
    $160.00

Manufacturing

  • Process Validation
    Price
    $100.00
    Select Templates
  • Rework Procedure
    Price
    $140.00
    Select Templates
  • Control of Non-Conforming Product Procedure
    Price
    $120.00
    Select Templates
  • Purchase the entire Manufacturing Department SoP package
    Price
    $360.00

Marketing-Sales

  • Feedback Procedure
    Price
    $140.00
    Select Templates
  • Complaint Handling Procedure
    Price
    $160.00
    Select Templates
  • Purchase the entire Marketing-Sales Department SoP package
    Price
    $300.00

Purchase

  • Purchasing Procedure
    Price
    $220.00
    Select Templates
  • Purchase the entire Purchase Department SoP package
    Price
    $220.00

Quality Assurance

  • Quality Policy
    Price
    $40.00
    Select Templates
  • Quality Manual
    Price
    $150.00
    Select Templates
  • Quality Objectives
    Price
    $20.00
    Select Templates
  • ​Corrective Action & Preventive Action Procedure
    Price
    $160.00
    Select Templates
  • Data Analysis Procedure
    Price
    $100.00
    Select Templates
  • Management Review Procedure
    Price
    $140.00
    Select Templates
  • Control of Records Procedure
    Price
    $100.00
    Select Templates
  • Control of Documents Procedure
    Price
    $160.00
    Select Templates
  • Procedure for Software Validation
    Price
    $100.00
    Select Templates
  • Change Control Procedure
    Price
    $140.00
    Select Templates
  • Medical Device File Procedure
    Price
    $100.00
    Select Templates
  • Purchase the entire Quality Assurance Department SoP package
    Price
    $1,210.00

Regulatory

  • ​Issuing Advisory Notice Procedure
    Price
    $120.00
    Select Templates
  • Reporting to Regulatory Authorities Procedure as per US FDA
    Price
    $120.00
    Select Templates
  • Purchase the entire Regulatory Department SoP package
    Price
    $240.00

Risk management

  • Risk Management Procedure
    Price
    $160.00
    Select Templates
  • Purchase the entire Risk management Department SoP package
    Price
    $160.00

Store

  • Preservation of Products Procedure
    Price
    $100.00
    Select Templates
  • All The Departmental Toolkits to Purchase the entire Freyr ISO 13485:2016 toolkit package
    Price
    $100.00

Work Environment

  • ​Monitoring & Controlling of Work Environment Procedure 
    Price
    $120.00
    Select Templates
  • Purchase the entire Environment Department SoP package
    Price
    $120.00

  • Purchase the entire Freyr ISO 13485:2016 toolkit package
    Price
    $3,650.00

Our experts will help you in

  • Product specific procedural requirements
  • Regional/Country specific QMS requirements to be incorporated in the procedures
  • Drafting specific procedure required as per the role taken by your organization
  • Integrating existing QMS with ISO 13485:2016 and vice versa

For more details Contact us today!