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13485 Store

The ISO 13485 Store provides instructions, materials, and services for your organization to become certified in the ISO 13485 Quality Standard.

Quality Terminologies & Documentations View more

- 13485:2003 to 2016 Transition Gap Checklist (2003>>2016)
  Price: $59
- 13485:2003 to 2016 Transition Quality Manual and Procedure Package
  Price: $497
- 13485:2003 to 2016 QMS Upgrade Instructions Transition
  Price: $199
- 13485:2016 Gap Analysis Checklist
  Price: $39
- 13485:2016 Forms Package
  Price: $100
- 13485:2016 Procedures Package
  Price: $300
- 13485:2016 Internal Auditor Training & Checklist Package
  Price: $545
- 13485:2016 Set of Employee Newsletters
  Price: $75
- 13485:2016 Quality Manual and Procedure Package
  Price: $397
- 13485:2016 Small Business Package
  Price: $697
- 13485:2016 All-in-One Documentation and Training Package
  Price: $997
- 13485:2016 Risk Management Exercise
  Price: $29
- 13485:2016 Internal Auditor Training Materials
  Price: $495
- 13485:2003 to 2016 Small Business Package Transition (2003>>2016)
  Price: $697
- 13485:2003 to 2016 All-in-One Documentation and Training Transition Package (2003>>2016)
  Price: $997
- 13185:2016 Flowcharts in MS Visio, SmartDraw, and PDF
  Price: $75
- 13485:2016 Internal Auditor Tools: Checklist, Procedure and Forms
  Price: $95
- Requirements of ISO 13485:2016 PPT Training Material
  Price: $85
- ISO 13485:2016 Employee Training PPT
  Price: $85
- 13485:2016 and FDA Compliant Gap Analysis Checklist
  Price: $59
- 13485:2016 and FDA Compliant Internal Auditor Tools: Checklist, Procedure and Forms
  Price: $95
- 13485:2016 and FDA Compliant Internal Auditor Training & Checklist Package
  Price: $545
- 13485: 2016 and FDA Compliant Quality Manual and Procedure Package
  Price: $497
- 13485: 2016 and FDA Compliant QMS Upgrade Instructions
  Price: $199

Recently Added

17025:2017 Internal Audit Tools: Checklist, Procedure and Forms

Price: $75

ISO 45001:2018 Internal Audit Checklist, Procedure, and Forms

Price: $75

Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment

Price: $90

AS9120 Rev B Internal Auditor Tools: Checklist, Procedure and Forms

Price: $75

Computer System Vendor Qualification and Management (RiskVal)

Price: $125

CFR Part 111 Current Good Manufacturing Practice (CGMP) Dietary Supplements Compliance Checklist

Price: $85

ISO 9001:2015 Quality Manual & Procedures Package

Price: $397

IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''

Price: $167

Quality Management System for a Pharmaceutical Company RFP Template

Price: $49

Product Feedback

ComplianceOnline always has Conferences available to keep me informed on changes to regulatory guidences. Steven is great presenter. He engage the group to discuss the topics in the presentation.

- Sr. Mfg Manager
FibroGen Inc.

Your Customer care services were extremely helpful. Thanks!

- Operations Program Manager
Abbott

I would like to Thanks to ComplianceOnline for coordinating this seminar and selecting good speaker. He was connected to subject with good example selection and material.

- Business Unit Manager
JAMAK

ComplianceOnline always has Conferences available to keep me informed on changes to regulatory guidences. Steven is great presenter. He engage the group to discuss the topics in the presentation.

- Sr. Mfg Manager
FibroGen Inc.

Best Sellers

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Seminars
Standards

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
By: Roger Cowan
Price: $249
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How to Conduct a HIPAA Risk Assessment
By: Brian Tuttle
Price: $249
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Building a Vendor Qualification Program for FDA Regulated Industries
By: Jonathan M Lewis
Price: $249
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FDA Regulations for Marketing OTC Drugs in the U.S.
By: Norma Skolnik
Price: $299
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Effective Annual U.S. FDA CGMP Training
By: John E Lincoln
Price: $249
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CDISC Mapping 1: Specifications and FDA Requirements
By: Sunil Gupta
Price: $299
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Extractables and Leachables in Early Phase Development
By: Wayland Rushing
Price: $279
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Advanced Tax Return Analysis for the Banker
By: David L Osburn
Price: $249
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1099 & W-9 Update - Complying with IRS Information Reporting Guidelines
By: Miles Hutchinson
Price: $249
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OSHA Recordkeeping for 2015: Beyond the OSHA 300 Summary
By: David A. Casavant
Price: $149
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Form I-9 and E-Verify, getting and staying compliant
By: Cathleen Hampton
Price: $149
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Affordable Care Act Updates: What Employers need to do to Prepare
By: Vanessa G Nelson
Price: $149
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Child Support: What Payroll Doesn't Know Can Hurt You
By: Vicki M. Lambert
Price: $229
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Detecting and Preventing Embezzlement in Your Organization
By: Peter Goldmann
Price: $249
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What Employers Need to Know About Severance Agreements
By: Janette Levey Frisch
Price: $229
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REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance: 2-Day In-Person ...

San Francisco, CA | Aug 6-7, 2020
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Preparing for FDA's New Import/Export Trauma in 2020: 2-Day In-Person Seminar by Ex-FDA Official

Virtual Seminar | Jul 16-17, 2020
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Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact: 2-Day In-Person Seminar...

Virtual Seminar | Jun 18-19, 2020
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Transforming Corporate Spending Processes: T&E and AP Best Practices and Digitization: 2-Day Virtual...

Los Angeles, CA | Aug 20-21, 2020
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Quality Control Laboratory Compliance - cGMPs and GLPs: One and a Half Day Virtual Seminar

Virtual Seminar | Jul 16-17, 2020
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FDA Recalls - Before You Start, and After You Finish : Virtual Seminar Seminar by Ex-FDA Official

Virtual Seminar | Jun 25-26, 2020
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Case Management Boot Camp: Strategies for Success in the Acute Care Setting and Beyond!...

Virtual Seminar | Jun 10, 2020
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Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR: 2-Day...

Virtual Seminar | Jun 3-4, 2020
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Validation, Verification and Transfer of Analytical Methods (Understanding and implementing...

Virtual Seminar | Jul 6-7, 2020
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Ensuring Compliance with Advertising and Promotional Requirements for Drugs and...

San Francisco, CA | Oct 22-23, 2020
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Data Integrity: FDA/EU Requirements and Implementation: 2-Day Workshop

Virtual Seminar | Jul 9-10, 2020
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21 CFR Part 11 Compliance for SaaS/Cloud Applications: 2-Day Virtual Seminar

Virtual Seminar | Jun 3-4, 2020
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Supplier and Contract Manufacturer Management: 2-Day Virtual Seminar

Virtual Seminar | June 3-4, 2020
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Project Management for Human Resources: 3-Day Certification Program

Miami, FL | Jul 29-31, 2020
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Biostatistics for the Non-Statistician: One-Day Virtual Seminar

Virtual Seminar | Jun 17, 2020
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General requirements for the competence of testing and calibration laboratories
Provider: ANSI
Price: $142
Add to Cart
IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
Provider: SEPT
Price: $299
Add to Cart
IEC 62304:2015 ''Medical Device Software - Software Life Cycle Processes''
Provider: SEPT
Price: $149
Add to Cart
ISO 45001:2018 Gap Analysis Checklist
Provider: 45001 Store
Price: $39
Add to Cart
Measurement management systems - Requirements for measurement processes and measuring equipment
Provider: ANSI
Price: $120
Add to Cart
Geometrical Product Specifications (GPS) - Geometrical tolerancing - Tolerances of form, orientation...
Provider: ANSI
Price: $250
Add to Cart
Templates and Plans for Software Configuration Management Documents-Version 6.0
Provider: SEPT
Price: $299
Add to Cart
Computer System Validation Master Plan
Provider: LabCompliance
Price: $90
Add to Cart
Zero Acceptance Number Sampling Plan for Receiving, In-Process and Final Inspection
Provider: Quality-Control-Plan
Price: $37
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Standard Operating Procedure: FDA Inspections
Provider: LabCompliance
Price: $49
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AS9003 Comprehensive Quality System Kit for Inspection and Test Quality Control System
Provider: At-PQC
Price: $397
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ISO 45001:2018 Internal Audit Checklist, Procedure, and Forms
Provider: 45001 Store
Price: $75
Add to Cart
Template for a Software Maintenance Plan - Fourth Edition
Provider: SEPT
Price: $99
Add to Cart
Sarbanes Oxley Treasury Risks and Controls
Provider: Audit Net
Price: $50
Add to Cart
ISO 45001:2018 Flowcharts in MS Visio, SmartDraw, and PDF
Provider: 45001 Store
Price: $75
Add to Cart

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13485 Store

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